Trial Outcomes & Findings for Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants (NCT NCT01229176)
NCT ID: NCT01229176
Last Updated: 2014-05-01
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
200 participants
Primary outcome timeframe
At 28 days after last vaccination as compared to baseline
Results posted on
2014-05-01
Participant Flow
Participant milestones
| Measure |
Vi-CRM, Adults
Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
|
Vi-PS, Adults
Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
|
Vi-CRM, Children
Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
Vi-PS, Children
Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
|
Vi-CRM, Older Infants
Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Older Infants
Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
|
Vi-CRM, Infants
Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Infants
Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
40
|
40
|
20
|
20
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
40
|
37
|
20
|
19
|
18
|
18
|
20
|
17
|
|
Overall Study
NOT COMPLETED
|
0
|
3
|
0
|
1
|
2
|
2
|
0
|
3
|
Reasons for withdrawal
| Measure |
Vi-CRM, Adults
Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
|
Vi-PS, Adults
Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
|
Vi-CRM, Children
Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
Vi-PS, Children
Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
|
Vi-CRM, Older Infants
Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Older Infants
Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
|
Vi-CRM, Infants
Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Infants
Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
|
|---|---|---|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
1
|
1
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
3
|
0
|
0
|
1
|
1
|
0
|
2
|
Baseline Characteristics
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adults, Children, Older Infants and Infants
Baseline characteristics by cohort
| Measure |
Vi-CRM, Adults
n=40 Participants
Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
|
Vi-PS, Adults
n=40 Participants
Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
|
Vi-CRM, Children
n=20 Participants
Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
Vi-PS, Children
n=20 Participants
Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
|
Vi-CRM, Older Infants
n=20 Participants
Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Older Infants
n=20 Participants
Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
|
Vi-CRM, Infants
n=20 Participants
Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Infants
n=20 Participants
Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|---|
|
Age, Customized
6 weeks to 8 weeks (infants)
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
20 participants
n=8 Participants
|
20 participants
n=24 Participants
|
40 participants
n=42 Participants
|
|
Age, Customized
9 months to 12 months (older infants)
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
20 participants
n=21 Participants
|
20 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
40 participants
n=42 Participants
|
|
Age, Customized
24 months 59 months (children)
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
20 participants
n=5 Participants
|
20 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
40 participants
n=42 Participants
|
|
Age, Customized
18 years to 45 years (adults)
|
40 participants
n=5 Participants
|
40 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
80 participants
n=42 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
12 Participants
n=21 Participants
|
12 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
8 Participants
n=24 Participants
|
97 Participants
n=42 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
8 Participants
n=8 Participants
|
10 Participants
n=8 Participants
|
12 Participants
n=24 Participants
|
103 Participants
n=42 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Asian
|
40 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
20 Participants
n=8 Participants
|
20 Participants
n=8 Participants
|
20 Participants
n=24 Participants
|
200 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=24 Participants
|
0 Participants
n=42 Participants
|
|
Region of Enrollment
Pakistan
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
20 participants
n=5 Participants
|
20 participants
n=4 Participants
|
20 participants
n=21 Participants
|
20 participants
n=8 Participants
|
20 participants
n=8 Participants
|
20 participants
n=24 Participants
|
160 participants
n=42 Participants
|
|
Region of Enrollment
India
|
20 participants
n=5 Participants
|
20 participants
n=7 Participants
|
0 participants
n=5 Participants
|
0 participants
n=4 Participants
|
0 participants
n=21 Participants
|
0 participants
n=8 Participants
|
0 participants
n=8 Participants
|
0 participants
n=24 Participants
|
40 participants
n=42 Participants
|
PRIMARY outcome
Timeframe: At 28 days after last vaccination as compared to baselinePopulation: Intention-to-treat analysis set, which included all participants who received the vaccination, those in whom at least one post-vaccination blood sample was collected, and those for whom at least one ELISA result was available.
Outcome measures
| Measure |
Vi-CRM, Adults
n=40 Participants
Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
|
Vi-PS, Adults
n=40 Participants
Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
|
Vi-CRM, Children
n=19 Participants
Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
Vi-PS, Children
n=19 Participants
Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
|
Vi-CRM, Older Infants
n=20 Participants
Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Older Infants
n=17 Participants
Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
|
Vi-CRM, Infants
n=20 Participants
Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Infants
n=17 Participants
Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer
|
100 percentage of subjects
Interval 91.0 to 100.0
|
85 percentage of subjects
Interval 70.0 to 94.0
|
100 percentage of subjects
Interval 82.0 to 100.0
|
89 percentage of subjects
Interval 67.0 to 99.0
|
95 percentage of subjects
Interval 75.0 to 100.0
|
0 percentage of subjects
Interval 0.0 to 20.0
|
85 percentage of subjects
Interval 62.0 to 97.0
|
6 percentage of subjects
Interval 0.0 to 29.0
|
PRIMARY outcome
Timeframe: At 6 months after last vaccination as compared to baselinePopulation: Intention-to-treat analysis set
Outcome measures
| Measure |
Vi-CRM, Adults
n=40 Participants
Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
|
Vi-PS, Adults
n=37 Participants
Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
|
Vi-CRM, Children
n=20 Participants
Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
Vi-PS, Children
n=19 Participants
Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
|
Vi-CRM, Older Infants
n=18 Participants
Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Older Infants
n=18 Participants
Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
|
Vi-CRM, Infants
n=20 Participants
Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Infants
n=17 Participants
Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
|
|---|---|---|---|---|---|---|---|---|
|
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer
|
90 percentage of subjects
Interval 76.0 to 97.0
|
81 percentage of subjects
Interval 65.0 to 92.0
|
95 percentage of subjects
Interval 75.0 to 100.0
|
68 percentage of subjects
Interval 43.0 to 87.0
|
89 percentage of subjects
Interval 65.0 to 99.0
|
6 percentage of subjects
Interval 0.0 to 27.0
|
25 percentage of subjects
Interval 9.0 to 49.0
|
0 percentage of subjects
Interval 0.0 to 20.0
|
PRIMARY outcome
Timeframe: At 28 days after last vaccinationPopulation: Intention-to-treat analysis set
Outcome measures
| Measure |
Vi-CRM, Adults
n=40 Participants
Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
|
Vi-PS, Adults
n=40 Participants
Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
|
Vi-CRM, Children
n=19 Participants
Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
Vi-PS, Children
n=19 Participants
Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
|
Vi-CRM, Older Infants
n=20 Participants
Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Older Infants
n=17 Participants
Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
|
Vi-CRM, Infants
n=20 Participants
Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Infants
n=17 Participants
Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
|
|---|---|---|---|---|---|---|---|---|
|
Anti-Vi ELISA Geometric Mean Concentration (GMC)
|
153 ELISA Units/mL
Interval 105.0 to 224.0
|
44 ELISA Units/mL
Interval 30.0 to 65.0
|
136 ELISA Units/mL
Interval 91.0 to 202.0
|
53 ELISA Units/mL
Interval 36.0 to 79.0
|
109 ELISA Units/mL
Interval 80.0 to 148.0
|
1.43 ELISA Units/mL
Interval 1.03 to 2.0
|
23 ELISA Units/mL
Interval 17.0 to 32.0
|
2.33 ELISA Units/mL
Interval 1.63 to 3.32
|
PRIMARY outcome
Timeframe: At 6 months after last vaccinationPopulation: Intention-to-treat analysis set
Outcome measures
| Measure |
Vi-CRM, Adults
n=40 Participants
Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
|
Vi-PS, Adults
n=37 Participants
Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
|
Vi-CRM, Children
n=20 Participants
Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
Vi-PS, Children
n=19 Participants
Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
|
Vi-CRM, Older Infants
n=18 Participants
Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Older Infants
n=18 Participants
Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
|
Vi-CRM, Infants
n=20 Participants
Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Infants
n=17 Participants
Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
|
|---|---|---|---|---|---|---|---|---|
|
Anti-Vi ELISA GMC
|
59 ELISA Units/mL
Interval 40.0 to 87.0
|
36 ELISA Units/mL
Interval 24.0 to 53.0
|
23 ELISA Units/mL
Interval 15.0 to 34.0
|
25 ELISA Units/mL
Interval 17.0 to 38.0
|
22 ELISA Units/mL
Interval 14.0 to 33.0
|
3.12 ELISA Units/mL
Interval 2.08 to 4.68
|
3.76 ELISA Units/mL
Interval 2.77 to 5.08
|
1.41 ELISA Units/mL
Interval 1.02 to 1.96
|
SECONDARY outcome
Timeframe: During the 7-day follow-up period after vaccinationPopulation: Analysis was done on as treated safety population.
Solicited local reactions were: Adults, children, older infants, infants: erythema, induration and pain/tenderness at the injection site. Solicited systemic reactions were: Adults: chills, malaise, myalgia, arthralgia, headache, fatigue, rash and fever. Children, older infants and infants: lethargy, irritability, vomiting, diarrhoea, loss of appetite, rash and fever (and persistent crying in infants).
Outcome measures
| Measure |
Vi-CRM, Adults
n=40 Participants
Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
|
Vi-PS, Adults
n=40 Participants
Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
|
Vi-CRM, Children
n=20 Participants
Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
Vi-PS, Children
n=20 Participants
Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
|
Vi-CRM, Older Infants
n=20 Participants
Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Older Infants
n=20 Participants
Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
|
Vi-CRM, Infants
n=20 Participants
Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Infants
n=19 Participants
Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
|
|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination
|
24 participants
|
27 participants
|
18 participants
|
17 participants
|
14 participants
|
19 participants
|
20 participants
|
19 participants
|
Adverse Events
Vi-CRM, Adults
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
Vi-PS, Adults
Serious events: 0 serious events
Other events: 29 other events
Deaths: 0 deaths
Vi-CRM, Children
Serious events: 2 serious events
Other events: 19 other events
Deaths: 0 deaths
Vi-PS, Children
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Vi-CRM, Older Infants
Serious events: 4 serious events
Other events: 18 other events
Deaths: 0 deaths
PNC13, Older Infants
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
Vi-CRM, Infants
Serious events: 5 serious events
Other events: 20 other events
Deaths: 0 deaths
PNC13, Infants
Serious events: 3 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Vi-CRM, Adults
n=40 participants at risk
Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
|
Vi-PS, Adults
n=40 participants at risk
Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
|
Vi-CRM, Children
n=20 participants at risk
Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
Vi-PS, Children
n=20 participants at risk
Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
|
Vi-CRM, Older Infants
n=20 participants at risk
Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Older Infants
n=20 participants at risk
Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
|
Vi-CRM, Infants
n=20 participants at risk
Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Infants
n=19 participants at risk
Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
|
|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Number of events 1 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
25.0%
5/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.5%
2/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Infections and infestations
Upper Respiratory Tract Infection
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Nervous system disorders
Febrile Convulsion
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
15.0%
3/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Infections and infestations
Measles
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.5%
2/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Infections and infestations
Respiratory Tract Infection
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.3%
1/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
Other adverse events
| Measure |
Vi-CRM, Adults
n=40 participants at risk
Adults (18 to 45 years) receiving 1 dose of NVGH Vi-CRM197 vaccine
|
Vi-PS, Adults
n=40 participants at risk
Adults (18 to 45 years) receiving 1 dose of licensed Vi Polysaccharide vaccine
|
Vi-CRM, Children
n=20 participants at risk
Children (24 to 59 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
Vi-PS, Children
n=20 participants at risk
Children (24 to 59 months) receiving 1 dose of licensed Vi Polysaccharide vaccine and 1 dose of Pneumococcal conjugate vaccine
|
Vi-CRM, Older Infants
n=20 participants at risk
Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Older Infants
n=20 participants at risk
Older Infants (9 to 12 months) receiving 2 doses of Pneumococcal conjugate vaccine
|
Vi-CRM, Infants
n=20 participants at risk
Infants (6 to 8 weeks) receiving 3 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Infants
n=19 participants at risk
Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
|
|---|---|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal Pain
|
2.5%
1/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
15.0%
3/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Ear and labyrinth disorders
Ear Pain
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
2.5%
1/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Eye disorders
Eye Pian
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.3%
1/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Gastrointestinal disorders
Abdominal Pian
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
25.0%
5/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
42.1%
8/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.3%
1/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
2.5%
1/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
30.0%
6/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
20.0%
4/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
45.0%
9/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
60.0%
12/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
35.0%
7/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
31.6%
6/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
15.0%
3/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
20.0%
4/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
15.8%
3/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
General disorders
Chills
|
15.0%
6/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
4/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
General disorders
Crying
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
General disorders
Fatigue
|
32.5%
13/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
32.5%
13/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
General disorders
Injection Site Erythema
|
10.0%
4/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
4/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
15.0%
3/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
45.0%
9/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
26.3%
5/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
General disorders
Injection Site Induration
|
10.0%
4/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
12.5%
5/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
20.0%
4/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
25.0%
5/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
45.0%
9/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
47.4%
9/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
General disorders
Injection Site Pain
|
42.5%
17/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
42.5%
17/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
80.0%
16/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
70.0%
14/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
25.0%
5/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
45.0%
9/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
85.0%
17/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
78.9%
15/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
General disorders
Irritability
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
15.0%
3/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
15.0%
3/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
55.0%
11/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
42.1%
8/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
General disorders
Malaise
|
12.5%
5/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
12.5%
5/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
General disorders
Pyrexia
|
2.5%
1/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
2.5%
1/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
35.0%
7/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
15.0%
3/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
45.0%
9/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
35.0%
7/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
55.0%
11/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
26.3%
5/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.3%
1/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Infections and infestations
Bronchiolitis
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Infections and infestations
Eye Infection
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.5%
2/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Infections and infestations
Fungal Infection
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.3%
1/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Infections and infestations
Influenza
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
25.0%
5/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
60.0%
12/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
70.0%
14/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
60.0%
12/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
57.9%
11/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Infections and infestations
Measles
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
20.0%
4/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.5%
2/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Infections and infestations
Oral Infection
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Infections and infestations
Skin Infection
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.3%
1/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
7.5%
3/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
7.5%
3/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
12.5%
5/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
7.5%
3/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Nervous system disorders
Headache
|
32.5%
13/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
35.0%
14/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Nervous system disorders
Somnolence
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
30.0%
6/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
20.0%
4/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
20.0%
4/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
15.0%
3/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
35.0%
7/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
21.1%
4/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Psychiatric disorders
Eating Disorder
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
20.0%
4/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
15.0%
3/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
30.0%
6/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
26.3%
5/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
7.5%
3/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.3%
1/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
1/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
2/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
30.0%
6/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
15.0%
3/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
40.0%
8/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
40.0%
8/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
50.0%
10/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
31.6%
6/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Respiratory, thoracic and mediastinal disorders
Nasal Congestion
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
25.0%
5/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
63.2%
12/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary Congestion
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.5%
2/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Skin and subcutaneous tissue disorders
Dermatitis Allergic
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.3%
1/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Skin and subcutaneous tissue disorders
Dermatitis Diaper
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.0%
1/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
15.0%
3/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
15.8%
3/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Skin and subcutaneous tissue disorders
Dry Skin
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.3%
1/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Skin and subcutaneous tissue disorders
Heat Rash
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
15.0%
3/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/40 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
20.0%
4/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
10.0%
2/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
0.00%
0/20 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
5.3%
1/19 • Solicited Adverse Events (AEs) were collected during 7-day follow period after each vaccination. Serious AEs were collected throughout the study period. Unsolicited AEs were collected collected during 28-day follow period after each vaccination.
Analysis was done on as treated safety population
|
Additional Information
Dr. Audino Podda
Novartis Vaccines Institute for Global Health
Phone: +39 0577 243496
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In the event that no publication of the Study results has been made by NVGH within twelve (12) months of Study database lock and no proposed publication is under discussion by the publication committee, Principal Investigator may publish its own Study results.
- Publication restrictions are in place
Restriction type: OTHER