Trial Outcomes & Findings for Safety, Immunogenicity and Efficacy of Shigella Conjugate Vaccines in 1-4 Year Olds in Israel (NCT NCT00368316)
NCT ID: NCT00368316
Last Updated: 2012-06-22
Results Overview
Number of participants with events per vaccine type and dose occuring in \>=5% of participants
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
2799 participants
Primary outcome timeframe
Monitored for 7 days per participant following each injection for initial group of 500, 2 days for extended study of up to 5500 additional children
Results posted on
2012-06-22
Participant Flow
Enrollment period: May 1, 2003 to January 31 3006. Surveillance period: May 1, 2003 to January 31 2008. Children were recruited from day care centers and health clinics in Israel
Participant milestones
| Measure |
S. Sonnei Conjugate Vaccine
Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
|
S. Flexneri 2a Conjugate Vaccine
Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
|
|---|---|---|
|
Overall Study
STARTED
|
1434
|
1365
|
|
Overall Study
COMPLETED
|
1392
|
1319
|
|
Overall Study
NOT COMPLETED
|
42
|
46
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety, Immunogenicity and Efficacy of Shigella Conjugate Vaccines in 1-4 Year Olds in Israel
Baseline characteristics by cohort
| Measure |
S. Sonnei Conjugate Vaccine
n=1434 Participants
Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
|
S. Flexneri 2a Conjugate Vaccine
n=1365 Participants
Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
|
Total
n=2799 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
1434 Participants
n=5 Participants
|
1365 Participants
n=7 Participants
|
2799 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
702 Participants
n=5 Participants
|
642 Participants
n=7 Participants
|
1344 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
732 Participants
n=5 Participants
|
723 Participants
n=7 Participants
|
1455 Participants
n=5 Participants
|
|
Region of Enrollment
Israel
|
1434 participants
n=5 Participants
|
1365 participants
n=7 Participants
|
2799 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Monitored for 7 days per participant following each injection for initial group of 500, 2 days for extended study of up to 5500 additional childrenNumber of participants with events per vaccine type and dose occuring in \>=5% of participants
Outcome measures
| Measure |
S. Sonnei Conjugate Vaccine
n=1434 Participants
Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
|
S. Flexneri 2a Conjugate Vaccine
n=1365 Participants
Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
|
|---|---|---|
|
Number of Participants With Adverse Events
local pain, dose 1
|
82 participants
|
61 participants
|
|
Number of Participants With Adverse Events
local pain, dose 2
|
79 participants
|
64 participants
|
|
Number of Participants With Adverse Events
fever, dose 1
|
56 participants
|
72 participants
|
|
Number of Participants With Adverse Events
fever, dose 2
|
36 participants
|
51 participants
|
SECONDARY outcome
Timeframe: Injections were administered 6 weeks apart and IgG anti-LPS levels determined >2 weeks after second vaccine dose. Each of the 15 sites also took a sample/week randomly chosen, for 2 years of follow up and blood samples from patients with diseaseAge-related homologous IgG anti-LPS levels
Outcome measures
| Measure |
S. Sonnei Conjugate Vaccine
n=1434 Participants
Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
|
S. Flexneri 2a Conjugate Vaccine
n=1365 Participants
Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
|
|---|---|---|
|
Geometric Mean Immunoglobulin G (IgG) Anti-Lipopolysaccharide (LPS) Levels
Age 1-2 years
|
1.40 ELISA units
No measure of dispersion was calculated. The medically responsible investigator in Israel died.
|
18.98 ELISA units
No measure of dispersion was calculated. The medically responsible investigator in Israel died.
|
|
Geometric Mean Immunoglobulin G (IgG) Anti-Lipopolysaccharide (LPS) Levels
Age >2-3 years
|
3.71 ELISA units
No measure of dispersion was calculated. The medically responsible investigator in Israel died.
|
26.96 ELISA units
No measure of dispersion was calculated. The medically responsible investigator in Israel died.
|
|
Geometric Mean Immunoglobulin G (IgG) Anti-Lipopolysaccharide (LPS) Levels
Age >3-4 years
|
6.38 ELISA units
No measure of dispersion was calculated. The medically responsible investigator in Israel died.
|
43.86 ELISA units
No measure of dispersion was calculated. The medically responsible investigator in Israel died.
|
SECONDARY outcome
Timeframe: During 2 years post vaccinationPercent efficacy is defined as ((disease rate of controls minus disease rate of vaccinees) divided by disease rate of controls) times 100
Outcome measures
| Measure |
S. Sonnei Conjugate Vaccine
n=1434 Participants
Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
|
S. Flexneri 2a Conjugate Vaccine
n=1365 Participants
Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
|
|---|---|---|
|
Percentage of Efficacy
Participants aged 1-2 years
|
3.8 Percent efficacy
Interval -101.1 to 46.5
|
-8.4 Percent efficacy
Interval -434.5 to 78.0
|
|
Percentage of Efficacy
Participants aged >2-3 years
|
35.5 Percent efficacy
Interval -56.4 to 73.4
|
22.5 Percent efficacy
Interval -244.4 to 82.6
|
|
Percentage of Efficacy
Participants aged >3-4 years
|
71.1 Percent efficacy
Interval -4.43 to 92.0
|
-3.6 Percent efficacy
Interval -1550.0 to 93.5
|
Adverse Events
S. Sonnei Conjugate Vaccine
Serious events: 0 serious events
Other events: 217 other events
Deaths: 0 deaths
S. Flexneri 2a Conjugate Vaccine
Serious events: 0 serious events
Other events: 197 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
S. Sonnei Conjugate Vaccine
n=1434 participants at risk
Shigella sonnei O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
|
S. Flexneri 2a Conjugate Vaccine
n=1365 participants at risk
Shigella flexneri 2a O-specific polysaccharide covalently bound to recombinant exoprotein A of Pseudomonas aeruginosa, administered in 2 injections of 0.5 mL containing 25 mcg of saccharide, 6 weeks apart
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
local pain, dose 1
|
5.7%
82/1434 • Number of events 82 • Local and systemic reactions were sought at 30 minutes, 6, 24 and 48 hours after vaccination by a structured questionnaire.
|
4.5%
61/1365 • Number of events 61 • Local and systemic reactions were sought at 30 minutes, 6, 24 and 48 hours after vaccination by a structured questionnaire.
|
|
Musculoskeletal and connective tissue disorders
local pain, dose 2
|
5.5%
79/1434 • Number of events 79 • Local and systemic reactions were sought at 30 minutes, 6, 24 and 48 hours after vaccination by a structured questionnaire.
|
4.7%
64/1365 • Number of events 64 • Local and systemic reactions were sought at 30 minutes, 6, 24 and 48 hours after vaccination by a structured questionnaire.
|
|
Investigations
fever, dose 1
|
3.9%
56/1434 • Number of events 56 • Local and systemic reactions were sought at 30 minutes, 6, 24 and 48 hours after vaccination by a structured questionnaire.
|
5.3%
72/1365 • Number of events 72 • Local and systemic reactions were sought at 30 minutes, 6, 24 and 48 hours after vaccination by a structured questionnaire.
|
|
General disorders
fever, dose 2
|
2.5%
36/1434 • Number of events 36 • Local and systemic reactions were sought at 30 minutes, 6, 24 and 48 hours after vaccination by a structured questionnaire.
|
5.3%
72/1365 • Number of events 72 • Local and systemic reactions were sought at 30 minutes, 6, 24 and 48 hours after vaccination by a structured questionnaire.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place