Trial Outcomes & Findings for Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants (NCT NCT01437267)
NCT ID: NCT01437267
Last Updated: 2014-04-10
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
120 participants
Primary outcome timeframe
At 28 days after last vaccination as compared to baseline
Results posted on
2014-04-10
Participant Flow
Participant milestones
| Measure |
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
|
20
|
20
|
20
|
20
|
20
|
20
|
|
Overall Study
COMPLETED
|
20
|
19
|
20
|
19
|
20
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
0
|
1
|
0
|
0
|
Reasons for withdrawal
| Measure |
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
|
0
|
0
|
|
Overall Study
Protocol Violation
|
0
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Children, Older Infants and Infants
Baseline characteristics by cohort
| Measure |
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=120 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
|
20 participants
n=21 Participants
|
20 participants
n=10 Participants
|
40 participants
n=115 Participants
|
|
Age, Customized
9 months to 12 months (older infants)
|
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=10 Participants
|
40 participants
n=115 Participants
|
|
Age, Customized
24 months 59 months (children)
|
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=10 Participants
|
40 participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
69 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
51 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Asian
|
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=10 Participants
|
120 Participants
n=115 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=10 Participants
|
0 Participants
n=115 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=10 Participants
|
0 Participants
n=115 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=10 Participants
|
0 Participants
n=115 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=10 Participants
|
0 Participants
n=115 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=10 Participants
|
0 Participants
n=115 Participants
|
|
Region of Enrollment
Philippines
|
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=10 Participants
|
120 participants
n=115 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, 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=20 Participants
Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Older Infants
n=19 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
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi Enzyme-linked Immunosorbent Assay (ELISA) Titer
|
100 percentage of subjects
Interval 83.0 to 100.0
|
100 percentage of subjects
Interval 82.0 to 100.0
|
100 percentage of subjects
Interval 83.0 to 100.0
|
11 percentage of subjects
Interval 1.0 to 33.0
|
100 percentage of subjects
Interval 83.0 to 100.0
|
10 percentage of subjects
Interval 1.0 to 32.0
|
PRIMARY outcome
Timeframe: At 6 months after last vaccination as compared to baselinePopulation: Intention-to-treat analysis set
Outcome measures
| Measure |
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=20 Participants
Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Older Infants
n=19 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
|
|---|---|---|---|---|---|---|
|
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer
|
90 percentage of subjects
Interval 68.0 to 99.0
|
95 percentage of subjects
Interval 74.0 to 100.0
|
70 percentage of subjects
Interval 46.0 to 88.0
|
11 percentage of subjects
Interval 1.0 to 33.0
|
70 percentage of subjects
Interval 46.0 to 88.0
|
5 percentage of subjects
Interval 0.0 to 25.0
|
PRIMARY outcome
Timeframe: At 28 days after last vaccinationPopulation: Intention-to-treat analysis set
Outcome measures
| Measure |
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=20 Participants
Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Older Infants
n=19 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
|
|---|---|---|---|---|---|---|
|
Anti-Vi ELISA Geometric Mean Concentration (GMC)
|
255 ELISA Units/mL
Interval 174.0 to 375.0
|
107 ELISA Units/mL
Interval 72.0 to 159.0
|
129 ELISA Units/mL
Interval 83.0 to 200.0
|
3.79 ELISA Units/mL
Interval 2.41 to 5.97
|
103 ELISA Units/mL
Interval 67.0 to 159.0
|
5.05 ELISA Units/mL
Interval 3.27 to 7.79
|
PRIMARY outcome
Timeframe: At 6 months after last vaccinationPopulation: Intention-to-treat analysis set
Outcome measures
| Measure |
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=20 Participants
Older Infants (9 to 12 months) receiving 2 doses of NVGH Vi-CRM197 vaccine
|
PNC13, Older Infants
n=19 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
|
|---|---|---|---|---|---|---|
|
Anti-Vi ELISA GMC
|
51 ELISA Units/mL
Interval 34.0 to 76.0
|
45 ELISA Units/mL
Interval 30.0 to 68.0
|
21 ELISA Units/mL
Interval 14.0 to 31.0
|
3.69 ELISA Units/mL
Interval 2.41 to 5.65
|
21 ELISA Units/mL
Interval 16.0 to 28.0
|
2.64 ELISA Units/mL
Interval 1.98 to 3.52
|
SECONDARY outcome
Timeframe: During the 7-day follow-up period after vaccinationPopulation: Analysis was done on as treated safety population
Solicited local reactions were: erythema, induration, pain/tenderness. Solicited systemic reactions were; lethargy, irritability, vomiting, diarrhoea, loss of appetite (and persistent crying in the older infants and infants age group)
Outcome measures
| Measure |
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
|
|---|---|---|---|---|---|---|
|
Number of Participants With Any Solicited Local and Systemic Reaction, After Any Vaccination
|
11 participants
|
10 participants
|
12 participants
|
17 participants
|
20 participants
|
19 participants
|
Adverse Events
Vi-CRM, Children
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Vi-PS, Children
Serious events: 1 serious events
Other events: 14 other events
Deaths: 0 deaths
Vi-CRM, Older Infants
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
PNC13, Older Infants
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Vi-CRM, Infants
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
PNC13, Infants
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
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=20 participants at risk
Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
|
|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|
Injury, poisoning and procedural complications
Animal bite
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
Other adverse events
| Measure |
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=20 participants at risk
Infants (6 to 8 weeks) receiving 3 doses of Pneumococcal conjugate vaccine
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Diarrhoea
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|
Gastrointestinal disorders
Vomiting
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|
General disorders
Crying
|
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.
|
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.
|
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.
|
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.
|
65.0%
13/20 • 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.
|
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.
|
|
General disorders
Induration
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|
General disorders
Injection site erythema
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|
General disorders
Injection site induration
|
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.
|
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.
|
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.
|
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.
|
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.
|
75.0%
15/20 • 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.
|
|
General disorders
Injection site pain
|
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.
|
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.
|
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.
|
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.
|
100.0%
20/20 • 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.
|
90.0%
18/20 • 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.
|
|
General disorders
Irritability
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|
General disorders
Pyrexia
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|
Immune system disorders
Hypersensitivity
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|
Infections and infestations
Gastroenteritis
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|
Infections and infestations
Impetigo
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|
Infections and infestations
Mumps
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|
Infections and infestations
Pneumonia
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|
Infections and infestations
Respiratory tract infections
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|
Infections and infestations
Rhinitis
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|
Infections and infestations
Viral infection
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|
Nervous system disorders
Somnolence
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
|
Psychiatric disorders
Eating disorders
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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