Trial Outcomes & Findings for Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old) (NCT NCT01123941)
NCT ID: NCT01123941
Last Updated: 2014-01-17
Results Overview
Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue.
COMPLETED
PHASE1
50 participants
During the 7-day period after vaccination
2014-01-17
Participant Flow
First subject enrolled: 03 MAY 2010 Last subject completed: 09 NOV 10 All subjects were enrolled at 1 center in Belgium
Participant milestones
| Measure |
NVGH Vi-CRM197
1 dose of 0.5 mL containing 25 mcg of Vi-CRM
|
Typherix
1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
|
|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
|
Overall Study
COMPLETED
|
23
|
24
|
|
Overall Study
NOT COMPLETED
|
2
|
1
|
Reasons for withdrawal
| Measure |
NVGH Vi-CRM197
1 dose of 0.5 mL containing 25 mcg of Vi-CRM
|
Typherix
1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
1
|
Baseline Characteristics
Safety and Immunogenicity of Vi-CRM197 Vaccine Against S. Typhi in Adult (18-40 Years Old)
Baseline characteristics by cohort
| Measure |
NVGH Vi-CRM197
n=25 Participants
1 dose of 0.5 mL containing 25 mcg of Vi-CRM
|
Typherix
n=25 Participants
1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
|
Total
n=50 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
50 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
21.9 years
STANDARD_DEVIATION 2.0 • n=5 Participants
|
23.9 years
STANDARD_DEVIATION 4.6 • n=7 Participants
|
22.9 years
STANDARD_DEVIATION 3.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Region of Enrollment
Belgium
|
25 participants
n=5 Participants
|
25 participants
n=7 Participants
|
50 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During the 7-day period after vaccinationSolicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue.
Outcome measures
| Measure |
NVGH Vi-CRM197
n=25 Participants
1 dose of 0.5 mL containing 25 mcg of Vi-CRM
|
Typherix
n=25 Participants
1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
|
|---|---|---|
|
Number of Subjects Reporting Any Post Immunization Reactions
|
23 participants
|
16 participants
|
PRIMARY outcome
Timeframe: During the 28-day period after vaccinationOutcome measures
| Measure |
NVGH Vi-CRM197
n=25 Participants
1 dose of 0.5 mL containing 25 mcg of Vi-CRM
|
Typherix
n=25 Participants
1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
|
|---|---|---|
|
Number of Subjects Reporting Adverse Events
|
23 participants
|
16 participants
|
PRIMARY outcome
Timeframe: During the 6-month period after vaccinationOutcome measures
| Measure |
NVGH Vi-CRM197
n=25 Participants
1 dose of 0.5 mL containing 25 mcg of Vi-CRM
|
Typherix
n=25 Participants
1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
|
|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
|
0 participants
|
2 participants
|
SECONDARY outcome
Timeframe: At 28 days after vaccinationOutcome measures
| Measure |
NVGH Vi-CRM197
n=25 Participants
1 dose of 0.5 mL containing 25 mcg of Vi-CRM
|
Typherix
n=25 Participants
1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
|
|---|---|---|
|
Anti-Vi ELISA Geometric Mean Concentration (GMC)
|
304 ELISA Units/mL
Interval 226.0 to 411.0
|
52 ELISA Units/mL
Interval 38.0 to 71.0
|
Adverse Events
NVGH Vi-CRM197
Typherix
Serious adverse events
| Measure |
NVGH Vi-CRM197
n=25 participants at risk
1 dose of 0.5 mL containing 25 mcg of Vi-CRM
|
Typherix
n=25 participants at risk
1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
SPONTANEOUS PNEUMOTHORAX RIGHT SIDE
|
0.00%
0/25 • AE during 28 days following vaccination (SAE for 6 months)
|
4.0%
1/25 • Number of events 1 • AE during 28 days following vaccination (SAE for 6 months)
|
|
Injury, poisoning and procedural complications
ANKLE FRACTURE
|
0.00%
0/25 • AE during 28 days following vaccination (SAE for 6 months)
|
4.0%
1/25 • Number of events 1 • AE during 28 days following vaccination (SAE for 6 months)
|
Other adverse events
| Measure |
NVGH Vi-CRM197
n=25 participants at risk
1 dose of 0.5 mL containing 25 mcg of Vi-CRM
|
Typherix
n=25 participants at risk
1 dose of 0.5 mL containing 25 mcg of Vi-polysaccharide
|
|---|---|---|
|
General disorders
injection site pain
|
84.0%
21/25 • AE during 28 days following vaccination (SAE for 6 months)
|
36.0%
9/25 • AE during 28 days following vaccination (SAE for 6 months)
|
|
General disorders
fatigue
|
48.0%
12/25 • AE during 28 days following vaccination (SAE for 6 months)
|
24.0%
6/25 • AE during 28 days following vaccination (SAE for 6 months)
|
|
Nervous system disorders
headache
|
44.0%
11/25 • AE during 28 days following vaccination (SAE for 6 months)
|
32.0%
8/25 • AE during 28 days following vaccination (SAE for 6 months)
|
|
General disorders
malaise
|
36.0%
9/25 • AE during 28 days following vaccination (SAE for 6 months)
|
16.0%
4/25 • AE during 28 days following vaccination (SAE for 6 months)
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
32.0%
8/25 • AE during 28 days following vaccination (SAE for 6 months)
|
0.00%
0/25 • AE during 28 days following vaccination (SAE for 6 months)
|
|
General disorders
injection site induration
|
28.0%
7/25 • AE during 28 days following vaccination (SAE for 6 months)
|
4.0%
1/25 • AE during 28 days following vaccination (SAE for 6 months)
|
|
General disorders
injection site erythema
|
16.0%
4/25 • AE during 28 days following vaccination (SAE for 6 months)
|
4.0%
1/25 • AE during 28 days following vaccination (SAE for 6 months)
|
|
Musculoskeletal and connective tissue disorders
back pain
|
4.0%
1/25 • AE during 28 days following vaccination (SAE for 6 months)
|
8.0%
2/25 • AE during 28 days following vaccination (SAE for 6 months)
|
|
Musculoskeletal and connective tissue disorders
muscoloskeletal stiffness
|
0.00%
0/25 • AE during 28 days following vaccination (SAE for 6 months)
|
8.0%
2/25 • AE during 28 days following vaccination (SAE for 6 months)
|
Additional Information
Dr. Audino Podda, MD
Novartis Vaccines Institute for Global Health
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER