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.

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

50 participants

Primary outcome timeframe

During the 7-day period after vaccination

Results posted on

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

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

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

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 vaccination

Solicited reactions collected during the 7-day period after vaccination are pain, erythema, induration, chills, malaise, myalgia, headache, arthralgia and fatigue.

Outcome measures

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 vaccination

Outcome measures

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 Adverse Events
23 participants
16 participants

PRIMARY outcome

Timeframe: During the 6-month period after vaccination

Outcome measures

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 Serious Adverse Events (SAEs)
0 participants
2 participants

SECONDARY outcome

Timeframe: At 28 days after vaccination

Outcome measures

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
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

Serious events: 0 serious events
Other events: 23 other events
Deaths: 0 deaths

Typherix

Serious events: 2 serious events
Other events: 16 other events
Deaths: 0 deaths

Serious adverse events

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

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

Phone: +39 0577 243496

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: OTHER