Trial Outcomes & Findings for Extension Study of H01_04TP to Evaluate the Booster Response Induced by Vi-CRM197 in Adults (NCT NCT01438996)
NCT ID: NCT01438996
Last Updated: 2014-03-24
Results Overview
To evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 3 after vaccination as as measured by enzyme-linked immunosorbent assay (ELISA)
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
51 participants
Primary outcome timeframe
At 3 days after vaccination
Results posted on
2014-03-24
Participant Flow
First subject enrolled: 17 OCT 11, Last subject completed: 13 DEC 11.
Participant milestones
| Measure |
NVGH Vi-CRM/NVGH Vi-CRM
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01\_04TP study
|
Vi-PS/NVGH Vi-CRM
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01\_04TP study
|
NVGH Vi-CRM
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
|
|---|---|---|---|
|
Overall Study
STARTED
|
18
|
13
|
20
|
|
Overall Study
COMPLETED
|
14
|
12
|
20
|
|
Overall Study
NOT COMPLETED
|
4
|
1
|
0
|
Reasons for withdrawal
| Measure |
NVGH Vi-CRM/NVGH Vi-CRM
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01\_04TP study
|
Vi-PS/NVGH Vi-CRM
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01\_04TP study
|
NVGH Vi-CRM
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
|
|---|---|---|---|
|
Overall Study
Not meeting Inclusion Criteria
|
4
|
1
|
0
|
Baseline Characteristics
Extension Study of H01_04TP to Evaluate the Booster Response Induced by Vi-CRM197 in Adults
Baseline characteristics by cohort
| Measure |
NVGH Vi-CRM/NVGH Vi-CRM
n=18 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01\_04TP study
|
Vi-PS/NVGH Vi-CRM
n=13 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01\_04TP study
|
NVGH Vi-CRM
n=20 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
|
Total
n=51 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
|
|
Age, Categorical
Between 18 and 65 years
|
18 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
51 Participants
n=4 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
|
|
Age, Continuous
|
25.3 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
26.3 years
STANDARD_DEVIATION 6.6 • n=7 Participants
|
26.0 years
STANDARD_DEVIATION 6.2 • n=5 Participants
|
25.8 years
STANDARD_DEVIATION 6.0 • n=4 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
34 Participants
n=4 Participants
|
|
Region of Enrollment
Belgium
|
18 participants
n=5 Participants
|
13 participants
n=7 Participants
|
20 participants
n=5 Participants
|
51 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: At 3 days after vaccinationTo evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 3 after vaccination as as measured by enzyme-linked immunosorbent assay (ELISA)
Outcome measures
| Measure |
NVGH Vi-CRM/NVGH Vi-CRM
n=14 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01\_04TP study
|
Vi-PS/NVGH Vi-CRM
n=12 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01\_04TP study
|
NVGH Vi-CRM
n=20 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
|
|---|---|---|---|
|
Anti-Vi ELISA Geometric Mean Concentration (GMC)
|
35 ELISA Units/mL
Interval 18.0 to 65.0
|
31 ELISA Units/mL
Interval 16.0 to 60.0
|
3.22 ELISA Units/mL
Interval 1.99 to 5.23
|
PRIMARY outcome
Timeframe: At 7 days after vaccinationTo evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 7 after vaccination as as measured by ELISA
Outcome measures
| Measure |
NVGH Vi-CRM/NVGH Vi-CRM
n=14 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01\_04TP study
|
Vi-PS/NVGH Vi-CRM
n=12 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01\_04TP study
|
NVGH Vi-CRM
n=20 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
|
|---|---|---|---|
|
Anti-Vi ELISA GMC
|
65 ELISA Units/mL
Interval 42.0 to 102.0
|
40 ELISA Units/mL
Interval 24.0 to 67.0
|
20 ELISA Units/mL
Interval 10.0 to 39.0
|
PRIMARY outcome
Timeframe: At 28 days after vaccinationTo evaluate the immunogenicity and the kinetics of the immune response induced by one dose of NVGH Vi-CRM197 at study day 28 after vaccination as as measured by ELISA
Outcome measures
| Measure |
NVGH Vi-CRM/NVGH Vi-CRM
n=14 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01\_04TP study
|
Vi-PS/NVGH Vi-CRM
n=12 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01\_04TP study
|
NVGH Vi-CRM
n=20 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
|
|---|---|---|---|
|
Anti-Vi ELISA GMC
|
44 ELISA Units/mL
Interval 28.0 to 69.0
|
50 ELISA Units/mL
Interval 35.0 to 71.0
|
111 ELISA Units/mL
Interval 78.0 to 156.0
|
PRIMARY outcome
Timeframe: At 3 days after vaccination as compared to baselineOutcome measures
| Measure |
NVGH Vi-CRM/NVGH Vi-CRM
n=14 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01\_04TP study
|
Vi-PS/NVGH Vi-CRM
n=12 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01\_04TP study
|
NVGH Vi-CRM
n=20 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
|
|---|---|---|---|
|
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers
|
0 percentage of subjects
Interval 0.0 to 23.0
|
0 percentage of subjects
Interval 0.0 to 26.0
|
0 percentage of subjects
Interval 0.0 to 17.0
|
PRIMARY outcome
Timeframe: At 7 days after vaccination as compared to baselineOutcome measures
| Measure |
NVGH Vi-CRM/NVGH Vi-CRM
n=14 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01\_04TP study
|
Vi-PS/NVGH Vi-CRM
n=12 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01\_04TP study
|
NVGH Vi-CRM
n=20 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
|
|---|---|---|---|
|
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers
|
7 percentage of subjects
Interval 0.0 to 34.0
|
0 percentage of subjects
Interval 0.0 to 26.0
|
60 percentage of subjects
Interval 36.0 to 81.0
|
PRIMARY outcome
Timeframe: At 28 days after vaccination as compared to baselineOutcome measures
| Measure |
NVGH Vi-CRM/NVGH Vi-CRM
n=14 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01\_04TP study
|
Vi-PS/NVGH Vi-CRM
n=12 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01\_04TP study
|
NVGH Vi-CRM
n=20 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
|
|---|---|---|---|
|
Percentage of Subjects With at Least 4-fold Increase in Anti-Vi ELISA Titers
|
0 percentage of subjects
Interval 0.0 to 23.0
|
17 percentage of subjects
Interval 2.0 to 48.0
|
100 percentage of subjects
Interval 83.0 to 100.0
|
SECONDARY 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, fatigue and fever.
Outcome measures
| Measure |
NVGH Vi-CRM/NVGH Vi-CRM
n=14 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01\_04TP study
|
Vi-PS/NVGH Vi-CRM
n=12 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01\_04TP study
|
NVGH Vi-CRM
n=20 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
|
|---|---|---|---|
|
Number of Subjects Reporting Any (Local, Systemic and Other) Post Vaccination Reaction
|
14 participants
|
12 participants
|
18 participants
|
SECONDARY outcome
Timeframe: During the 28-day period after vaccinationAE during 28 days after vaccination(including solicited reactions during 7 days after vaccination)
Outcome measures
| Measure |
NVGH Vi-CRM/NVGH Vi-CRM
n=14 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01\_04TP study
|
Vi-PS/NVGH Vi-CRM
n=12 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01\_04TP study
|
NVGH Vi-CRM
n=20 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
|
|---|---|---|---|
|
Number of Subjects Reporting AE
|
14 participants
|
12 participants
|
20 participants
|
SECONDARY outcome
Timeframe: During the 28-day period after vaccinationOutcome measures
| Measure |
NVGH Vi-CRM/NVGH Vi-CRM
n=14 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01\_04TP study
|
Vi-PS/NVGH Vi-CRM
n=12 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01\_04TP study
|
NVGH Vi-CRM
n=20 Participants
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
|
|---|---|---|---|
|
Number of Subjects Reporting Serious Adverse Events (SAEs)
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
NVGH Vi-CRM/NVGH Vi-CRM
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Vi-PS/NVGH Vi-CRM
Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths
NVGH Vi-CRM
Serious events: 0 serious events
Other events: 20 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
NVGH Vi-CRM/NVGH Vi-CRM
n=14 participants at risk
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of NVGH Vi-CRM197 5.0 mcg in H01\_04TP study
|
Vi-PS/NVGH Vi-CRM
n=12 participants at risk
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in adults who received 1 dose of Vi-polysaccharide (PS) in H01\_04TP study
|
NVGH Vi-CRM
n=20 participants at risk
One 0.5 mL dose of NVGH Vi-CRM197 5.0 mcg in naive adults
|
|---|---|---|---|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/14
|
16.7%
2/12
|
5.0%
1/20
|
|
Gastrointestinal disorders
diarrhoea
|
0.00%
0/14
|
8.3%
1/12
|
5.0%
1/20
|
|
Gastrointestinal disorders
nausea
|
7.1%
1/14
|
8.3%
1/12
|
0.00%
0/20
|
|
General disorders
chills
|
21.4%
3/14
|
8.3%
1/12
|
5.0%
1/20
|
|
General disorders
fatigue
|
50.0%
7/14
|
58.3%
7/12
|
25.0%
5/20
|
|
General disorders
injection site erythema
|
21.4%
3/14
|
0.00%
0/12
|
0.00%
0/20
|
|
General disorders
injection site induration
|
0.00%
0/14
|
0.00%
0/12
|
20.0%
4/20
|
|
General disorders
injection site pain
|
100.0%
14/14
|
83.3%
10/12
|
75.0%
15/20
|
|
General disorders
malaise
|
28.6%
4/14
|
50.0%
6/12
|
25.0%
5/20
|
|
Infections and infestations
gastroenteritis
|
7.1%
1/14
|
8.3%
1/12
|
5.0%
1/20
|
|
Infections and infestations
nasopharingitis
|
42.9%
6/14
|
25.0%
3/12
|
15.0%
3/20
|
|
Infections and infestations
oral herpes
|
0.00%
0/14
|
8.3%
1/12
|
5.0%
1/20
|
|
Infections and infestations
rhinitis
|
14.3%
2/14
|
0.00%
0/12
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
arthralgia
|
7.1%
1/14
|
0.00%
0/12
|
0.00%
0/20
|
|
Musculoskeletal and connective tissue disorders
myalgia
|
28.6%
4/14
|
16.7%
2/12
|
10.0%
2/20
|
|
Nervous system disorders
dizziness
|
7.1%
1/14
|
0.00%
0/12
|
0.00%
0/20
|
|
Nervous system disorders
headache
|
42.9%
6/14
|
66.7%
8/12
|
45.0%
9/20
|
|
Nervous system disorders
syncope
|
7.1%
1/14
|
0.00%
0/12
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/14
|
16.7%
2/12
|
10.0%
2/20
|
|
Respiratory, thoracic and mediastinal disorders
epistaxis
|
7.1%
1/14
|
0.00%
0/12
|
0.00%
0/20
|
|
Respiratory, thoracic and mediastinal disorders
oropharyngeal pain
|
7.1%
1/14
|
8.3%
1/12
|
5.0%
1/20
|
|
Skin and subcutaneous tissue disorders
ecchymosis
|
0.00%
0/14
|
8.3%
1/12
|
0.00%
0/20
|
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, provided that he furnishes NVGH with a copy of the proposed publication for NVGH's review and comment, at least 1 month prior to submission to a publisher or disclosure to any third party.
- Publication restrictions are in place
Restriction type: OTHER