Trial Outcomes & Findings for Study of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine in Japanese Subjects (NCT NCT01608815)
NCT ID: NCT01608815
Last Updated: 2014-05-12
Results Overview
Anti Vi antibodies were measured by Enzyme-Linked ImmunoSorbent Assay (ELISA).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
200 participants
Primary outcome timeframe
Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Results posted on
2014-05-12
Participant Flow
The study participants were enrolled from 26 May 2012 to 31 August 2012 at 4 clinic centers in Japan.
A total of 200 participants who met all of the inclusion and none of the exclusion criteria were vaccinated in this study.
Participant milestones
| Measure |
Adults (Group 1)
Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
|
Adolescents (Group 2)
Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
|
Children (Group 3)
Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
|
|---|---|---|---|
|
Overall Study
STARTED
|
188
|
7
|
5
|
|
Overall Study
COMPLETED
|
188
|
7
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine in Japanese Subjects
Baseline characteristics by cohort
| Measure |
Adults (Group 1)
n=188 Participants
Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
|
Adolescents (Group 2)
n=7 Participants
Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
|
Children (Group 3)
n=5 Participants
Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
|
Total
n=200 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
188 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
188 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
|
37.2 Years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
15.6 Years
STANDARD_DEVIATION 2.0 • n=7 Participants
|
5.2 Years
STANDARD_DEVIATION 3.8 • n=5 Participants
|
35.7 Years
STANDARD_DEVIATION 12.7 • n=4 Participants
|
|
Sex: Female, Male
Female
|
72 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
76 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
116 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
124 Participants
n=4 Participants
|
|
Region of Enrollment
Japan
|
188 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
200 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Day 0 (pre-vaccination) to Day 28 (post-vaccination)Population: Vi antibody titers were assessed in the Immunology Analysis Set.
Anti Vi antibodies were measured by Enzyme-Linked ImmunoSorbent Assay (ELISA).
Outcome measures
| Measure |
Adults (Group 1)
n=188 Participants
Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
|
Dolescents (Group 2)
n=7 Participants
Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
|
Children (Group 3)
n=5 Participants
Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
|
|---|---|---|---|
|
Number of Participants With At Least a 4-Fold Rise in Vi Antibody Titers Following Vaccination With a Typhoid Vi Polysaccharide Vaccine
|
173 Participants
|
6 Participants
Interval 0.0 to 0.0
|
5 Participants
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Day 0 (pre-vaccination) and Day 28 post-vaccinationPopulation: Geometric Mean Titers were assessed in the Immunology Analysis Set.
Anti-Vi antibodies were measured by enzyme-linked immunosorbent assay (ELISA)
Outcome measures
| Measure |
Adults (Group 1)
n=188 Participants
Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
|
Dolescents (Group 2)
n=7 Participants
Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
|
Children (Group 3)
n=5 Participants
Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
|
|---|---|---|---|
|
Geometric Mean Titers (GMTs) of Antibodies to Vi Antibody Before and Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
GMT (pre-vaccination)
|
6.6 Titers
Interval 5.8 to 7.4
|
10.2 Titers
Interval 2.9 to 35.9
|
3.7 Titers
The 95% Confidence Interval was not calculated as the titer values are less than the Lower Level of Quantitation
|
|
Geometric Mean Titers (GMTs) of Antibodies to Vi Antibody Before and Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
GMT (post-vaccination)
|
148.6 Titers
Interval 126.9 to 174.0
|
320.0 Titers
Interval 230.6 to 444.2
|
501.7 Titers
Interval 305.3 to 824.5
|
SECONDARY outcome
Timeframe: Day 28 post-vaccinationPopulation: Geometric Mean Titer Ratios were assessed in the Immunology Analysis Set.
Anti-Vi antibodies were measured by enzyme-linked immunosorbent assay (ELISA).
Outcome measures
| Measure |
Adults (Group 1)
n=188 Participants
Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
|
Dolescents (Group 2)
n=7 Participants
Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
|
Children (Group 3)
n=5 Participants
Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
|
|---|---|---|---|
|
Geometric Mean Titer Ratios (GMTRs) of Antibodies to Vi Antibody Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
|
22.6 Ratio
Interval 19.1 to 26.8
|
31.4 Ratio
Interval 9.2 to 107.9
|
135.6 Ratio
Interval 82.5 to 222.8
|
SECONDARY outcome
Timeframe: Day 0 up to Day 7 post-vaccinationPopulation: Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.
Solicited injection site: Pain, Erythema, and Swelling; Solicited systemic reactions: Fever (Temperature), Headache, Malaise, Myalgia. Grade 3 injection site (children): Pain Incapacitating, unable to perform usual activities; Erythema and Swelling ≥ 50 mm; Grade 3 injection site (adults and adolescents): Pain, Significant, prevents daily activity; Erythema and Swelling, \>100 mm. Grade 3 systemic reactions: Fever, ≥39˚C; Headache, Malaise, and Myalgia, Significant, prevents daily activity.
Outcome measures
| Measure |
Adults (Group 1)
n=188 Participants
Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
|
Dolescents (Group 2)
n=7 Participants
Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
|
Children (Group 3)
n=5 Participants
Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
|
|---|---|---|---|
|
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Injection site Pain
|
139 Participants
|
6 Participants
Interval 0.0 to 0.0
|
3 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Grade 3 Injection site Pain
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Injection site Erythema
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
2 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Grade 3 Injection site Erythema
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Injection site Swelling
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Grade 3 Injection site Swelling
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Fever
|
2 Participants
|
0 Participants
Interval 0.0 to 0.0
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Grade 3 Fever
|
0 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Headache
|
14 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Grade 3 Headache
|
1 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Malaise
|
23 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Grade 3 Malaise
|
2 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Myalgia
|
93 Participants
|
4 Participants
Interval 0.0 to 0.0
|
1 Participants
Interval 0.0 to 0.0
|
|
Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Grade 3 Myalgia
|
2 Participants
|
0 Participants
Interval 0.0 to 0.0
|
0 Participants
Interval 0.0 to 0.0
|
Adverse Events
Adults (Group 1)
Serious events: 1 serious events
Other events: 139 other events
Deaths: 0 deaths
Adolescents (Group 2)
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Children (Group 3)
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adults (Group 1)
n=188 participants at risk
Participants ≥18 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
|
Adolescents (Group 2)
n=7 participants at risk
Participants 12 to 17 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
|
Children (Group 3)
n=5 participants at risk
Participants 2 to 11 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
|
|---|---|---|---|
|
Hepatobiliary disorders
Cholecystitis acute
|
0.53%
1/188 • Number of events 1 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
0.00%
0/7 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
0.00%
0/5 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
Other adverse events
| Measure |
Adults (Group 1)
n=188 participants at risk
Participants ≥18 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
|
Adolescents (Group 2)
n=7 participants at risk
Participants 12 to 17 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
|
Children (Group 3)
n=5 participants at risk
Participants 2 to 11 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
|
|---|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
3.7%
7/188 • Number of events 7 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
0.00%
0/7 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
|
Gastrointestinal disorders
Stomatitis
|
0.53%
1/188 • Number of events 1 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
14.3%
1/7 • Number of events 1 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
0.00%
0/5 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
|
General disorders
Injection site Pain
|
73.9%
139/188 • Number of events 139 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
85.7%
6/7 • Number of events 6 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
60.0%
3/5 • Number of events 3 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
|
General disorders
Injection site Erythema
|
0.00%
0/188 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
0.00%
0/7 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
40.0%
2/5 • Number of events 2 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
|
General disorders
Fever
|
1.1%
2/188 • Number of events 2 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
0.00%
0/7 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
|
Nervous system disorders
Headache
|
7.4%
14/188 • Number of events 14 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
0.00%
0/7 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
0.00%
0/5 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
|
General disorders
Malaise
|
12.2%
23/188 • Number of events 23 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
0.00%
0/7 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
0.00%
0/5 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
49.5%
93/188 • Number of events 93 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
57.1%
4/7 • Number of events 4 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
20.0%
1/5 • Number of events 1 • Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Sponsor must have the opportunity to review at least 60 days prior to submission for publication or presentation. If review indicates that potentially patentable subject matter would be disclosed, publication or public disclosure may be delayed for a maximum of an additional 60 days to allow for filing the necessary patent applications.
- Publication restrictions are in place
Restriction type: OTHER