Trial Outcomes & Findings for Safety and Immunogenicity of Three Formulations of Vi-CRM197 Vaccine Against S. Typhi in Adults (18-40 Years Old) (NCT NCT01193907)
NCT ID: NCT01193907
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
88 participants
Primary outcome timeframe
During the 7-day period after vaccination
Results posted on
2014-01-17
Participant Flow
Date of first enrollment: 04 OCT 10 Date of last visit: 18 NOV 10
Participant milestones
| Measure |
NVGH Vi-CRM197 12.5 Mcg
1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
|
NVGH Vi-CRM197 5.0 Mcg
1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
|
NVGH Vi-CRM197 1.25 Mcg
1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
|
Typherix
1 dose of 0.5 mL containing 25 mcg of Vi-PS
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
22
|
22
|
22
|
22
|
|
Overall Study
COMPLETED
|
21
|
22
|
22
|
21
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Immunogenicity of Three Formulations of Vi-CRM197 Vaccine Against S. Typhi in Adults (18-40 Years Old)
Baseline characteristics by cohort
| Measure |
NVGH Vi-CRM197 12.5 Mcg
n=22 Participants
1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
|
NVGH Vi-CRM197 5.0 Mcg
n=22 Participants
1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
|
NVGH Vi-CRM197 1.25 Mcg
n=22 Participants
1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
|
Typherix
n=22 Participants
1 dose of 0.5 mL containing 25 mcg of Vi-PS
|
Total
n=88 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
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
22 Participants
n=4 Participants
|
88 Participants
n=21 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Age, Continuous
|
24.3 years
STANDARD_DEVIATION 4.9 • n=5 Participants
|
24.3 years
STANDARD_DEVIATION 5.4 • n=7 Participants
|
24.0 years
STANDARD_DEVIATION 5.7 • n=5 Participants
|
23.8 years
STANDARD_DEVIATION 5.5 • n=4 Participants
|
24.1 years
STANDARD_DEVIATION 5.3 • n=21 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
61 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
27 Participants
n=21 Participants
|
|
Region of Enrollment
Belgium
|
22 participants
n=5 Participants
|
22 participants
n=7 Participants
|
22 participants
n=5 Participants
|
22 participants
n=4 Participants
|
88 participants
n=21 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 12.5 Mcg
n=21 Participants
1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
|
NVGH Vi-CRM197 5.0 Mcg
n=22 Participants
1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
|
NVGH Vi-CRM197 1.25 Mcg
n=22 Participants
1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
|
Typherix
n=22 Participants
1 dose of 0.5 mL containing 25 mcg of Vi-PS
|
|---|---|---|---|---|
|
Number of Subjects Reporting Any Post Immunization Reactions
|
18 participants
|
19 participants
|
22 participants
|
16 participants
|
PRIMARY outcome
Timeframe: During the 28-day period after vaccinationOutcome measures
| Measure |
NVGH Vi-CRM197 12.5 Mcg
n=21 Participants
1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
|
NVGH Vi-CRM197 5.0 Mcg
n=22 Participants
1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
|
NVGH Vi-CRM197 1.25 Mcg
n=22 Participants
1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
|
Typherix
n=22 Participants
1 dose of 0.5 mL containing 25 mcg of Vi-PS
|
|---|---|---|---|---|
|
Number of Subjects Reporting Adverse Events
|
11 participants
|
16 participants
|
18 participants
|
15 participants
|
PRIMARY outcome
Timeframe: At 28 days after vaccinationOutcome measures
| Measure |
NVGH Vi-CRM197 12.5 Mcg
n=21 Participants
1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
|
NVGH Vi-CRM197 5.0 Mcg
n=21 Participants
1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
|
NVGH Vi-CRM197 1.25 Mcg
n=19 Participants
1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
|
Typherix
n=20 Participants
1 dose of 0.5 mL containing 25 mcg of Vi-PS
|
|---|---|---|---|---|
|
Anti-Vi ELISA (Enzyme Linked Immunosorbent Assay) Geometric Mean Concentration (GMC)
|
192 GMC
Interval 129.0 to 286.0
|
111 GMC
Interval 75.0 to 165.0
|
63 GMC
Interval 41.0 to 95.0
|
37 GMC
Interval 24.0 to 55.0
|
PRIMARY outcome
Timeframe: At 28 days after vaccinationOutcome measures
| Measure |
NVGH Vi-CRM197 12.5 Mcg
n=21 Participants
1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
|
NVGH Vi-CRM197 5.0 Mcg
n=21 Participants
1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
|
NVGH Vi-CRM197 1.25 Mcg
n=19 Participants
1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
|
Typherix
n=20 Participants
1 dose of 0.5 mL containing 25 mcg of Vi-PS
|
|---|---|---|---|---|
|
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titer
|
100 percentage of subjects
Interval 84.0 to 100.0
|
100 percentage of subjects
Interval 84.0 to 100.0
|
95 percentage of subjects
Interval 74.0 to 100.0
|
95 percentage of subjects
Interval 75.0 to 100.0
|
Adverse Events
NVGH Vi-CRM197 12.5 Mcg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
NVGH Vi-CRM197 5.0 Mcg
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
NVGH Vi-CRM197 1.25 Mcg
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Typherix
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NVGH Vi-CRM197 12.5 Mcg
n=21 participants at risk
1 dose of 0.5 mL containing 12.5 mcg of Vi-CRM
|
NVGH Vi-CRM197 5.0 Mcg
n=22 participants at risk
1 dose of 0.5 mL containing 5.0 mcg of Vi-CRM
|
NVGH Vi-CRM197 1.25 Mcg
n=22 participants at risk
1 dose of 0.5 mL containing 1.25 mcg of Vi-CRM
|
Typherix
n=22 participants at risk
1 dose of 0.5 mL containing 25 mcg of Vi-PS
|
|---|---|---|---|---|
|
Gastrointestinal disorders
diarrhoea
|
4.8%
1/21
|
13.6%
3/22
|
22.7%
5/22
|
4.5%
1/22
|
|
Gastrointestinal disorders
nausea
|
0.00%
0/21
|
18.2%
4/22
|
9.1%
2/22
|
0.00%
0/22
|
|
General disorders
chills
|
4.8%
1/21
|
9.1%
2/22
|
9.1%
2/22
|
9.1%
2/22
|
|
General disorders
Fatigue
|
33.3%
7/21
|
50.0%
11/22
|
36.4%
8/22
|
31.8%
7/22
|
|
General disorders
injection site erythema
|
14.3%
3/21
|
9.1%
2/22
|
9.1%
2/22
|
0.00%
0/22
|
|
General disorders
injection site induration
|
14.3%
3/21
|
18.2%
4/22
|
13.6%
3/22
|
9.1%
2/22
|
|
General disorders
injection site pain
|
81.0%
17/21
|
72.7%
16/22
|
95.5%
21/22
|
40.9%
9/22
|
|
General disorders
malaise
|
19.0%
4/21
|
18.2%
4/22
|
22.7%
5/22
|
18.2%
4/22
|
|
Infections and infestations
nasopharingitis
|
19.0%
4/21
|
40.9%
9/22
|
22.7%
5/22
|
22.7%
5/22
|
|
Infections and infestations
viral URTI
|
9.5%
2/21
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
9.5%
2/21
|
0.00%
0/22
|
0.00%
0/22
|
0.00%
0/22
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
23.8%
5/21
|
18.2%
4/22
|
18.2%
4/22
|
13.6%
3/22
|
|
Nervous system disorders
headache
|
52.4%
11/21
|
50.0%
11/22
|
54.5%
12/22
|
45.5%
10/22
|
|
Skin and subcutaneous tissue disorders
rash
|
0.00%
0/21
|
0.00%
0/22
|
9.1%
2/22
|
0.00%
0/22
|
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