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Study of a Single Dose of SP093 Typhoid Vi Polysaccharide Vaccine in Japanese Subjects

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ClinicalTrials.gov Identifier: NCT01608815
Recruitment Status : Completed
First Posted : May 31, 2012
Results First Posted : May 12, 2014
Last Update Posted : May 12, 2014
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Conditions Salmonella Infections
Typhoid Fever
Bacterial Infections
Intervention Biological: Typhoid Vi polysaccharide
Enrollment 200
Recruitment Details The study participants were enrolled from 26 May 2012 to 31 August 2012 at 4 clinic centers in Japan.
Pre-assignment Details A total of 200 participants who met all of the inclusion and none of the exclusion criteria were vaccinated in this study.
Arm/Group Title Adults (Group 1) Adolescents (Group 2) Children (Group 3)
Hide Arm/Group Description Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
Period Title: Overall Study
Started 188 7 5
Completed 188 7 5
Not Completed 0 0 0
Arm/Group Title Adults (Group 1) Adolescents (Group 2) Children (Group 3) Total
Hide Arm/Group Description Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine Total of all reporting groups
Overall Number of Baseline Participants 188 7 5 200
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 188 participants 7 participants 5 participants 200 participants
<=18 years
0
   0.0%
7
 100.0%
5
 100.0%
12
   6.0%
Between 18 and 65 years
188
 100.0%
0
   0.0%
0
   0.0%
188
  94.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 188 participants 7 participants 5 participants 200 participants
37.2  (11.4) 15.6  (2.0) 5.2  (3.8) 35.7  (12.7)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 188 participants 7 participants 5 participants 200 participants
Female
72
  38.3%
3
  42.9%
1
  20.0%
76
  38.0%
Male
116
  61.7%
4
  57.1%
4
  80.0%
124
  62.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 188 participants 7 participants 5 participants 200 participants
188 7 5 200
1.Primary Outcome
Title Number of Participants With At Least a 4-Fold Rise in Vi Antibody Titers Following Vaccination With a Typhoid Vi Polysaccharide Vaccine
Hide Description Anti Vi antibodies were measured by Enzyme-Linked ImmunoSorbent Assay (ELISA).
Time Frame Day 0 (pre-vaccination) to Day 28 (post-vaccination)
Hide Outcome Measure Data
Hide Analysis Population Description
Vi antibody titers were assessed in the Immunology Analysis Set.
Arm/Group Title Adults (Group 1) Dolescents (Group 2) Children (Group 3)
Hide Arm/Group Description:
Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
Overall Number of Participants Analyzed 188 7 5
Measure Type: Number
Unit of Measure: Participants
173 6 5
2.Secondary Outcome
Title Geometric Mean Titers (GMTs) of Antibodies to Vi Antibody Before and Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Hide Description Anti-Vi antibodies were measured by enzyme-linked immunosorbent assay (ELISA)
Time Frame Day 0 (pre-vaccination) and Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Titers were assessed in the Immunology Analysis Set.
Arm/Group Title Adults (Group 1) Adolescents (Group 2) Children (Group 3)
Hide Arm/Group Description:
Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
Overall Number of Participants Analyzed 188 7 5
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titers
GMT (pre-vaccination)
6.6
(5.8 to 7.4)
10.2
(2.9 to 35.9)
3.7 [1] 
(NA to NA)
GMT (post-vaccination)
148.6
(126.9 to 174.0)
320.0
(230.6 to 444.2)
501.7
(305.3 to 824.5)
[1]
The 95% Confidence Interval was not calculated as the titer values are less than the Lower Level of Quantitation
3.Secondary Outcome
Title Geometric Mean Titer Ratios (GMTRs) of Antibodies to Vi Antibody Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Hide Description Anti-Vi antibodies were measured by enzyme-linked immunosorbent assay (ELISA).
Time Frame Day 28 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Geometric Mean Titer Ratios were assessed in the Immunology Analysis Set.
Arm/Group Title Adults (Group 1) Adolescents (Group 2) Children (Group 3)
Hide Arm/Group Description:
Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
Overall Number of Participants Analyzed 188 7 5
Geometric Mean (95% Confidence Interval)
Unit of Measure: Ratio
22.6
(19.1 to 26.8)
31.4
(9.2 to 107.9)
135.6
(82.5 to 222.8)
4.Secondary Outcome
Title Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine
Hide Description 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.
Time Frame Day 0 up to Day 7 post-vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Solicited injection site reactions and systemic reactions were assessed in the Safety Analysis Set.
Arm/Group Title Adults (Group 1) Adolescents (Group 2) Children (Group 3)
Hide Arm/Group Description:
Participants ≥18 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
Participants 12 to 17 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
Participants 2 to 11 years of age received a single dose (0.5 mL) of Typhoid Vi Polysaccharide Vaccine
Overall Number of Participants Analyzed 188 7 5
Measure Type: Number
Unit of Measure: Participants
Injection site Pain 139 6 3
Grade 3 Injection site Pain 0 0 0
Injection site Erythema 0 0 2
Grade 3 Injection site Erythema 0 0 0
Injection site Swelling 1 0 0
Grade 3 Injection site Swelling 0 0 0
Fever 2 0 1
Grade 3 Fever 0 0 0
Headache 14 0 0
Grade 3 Headache 1 0 0
Malaise 23 0 0
Grade 3 Malaise 2 0 0
Myalgia 93 4 1
Grade 3 Myalgia 2 0 0
Time Frame Adverse event data were collected from Day 0 (post vaccination) up to Day 28 post vaccination.
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Adults (Group 1) Adolescents (Group 2) Children (Group 3)
Hide Arm/Group Description Participants ≥18 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine Participants 12 to 17 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine Participants 2 to 11 years of age received a single dose of Typhoid Vi Polysaccharide Vaccine
All-Cause Mortality
Adults (Group 1) Adolescents (Group 2) Children (Group 3)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Adults (Group 1) Adolescents (Group 2) Children (Group 3)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/188 (0.53%)      0/7 (0.00%)      0/5 (0.00%)    
Hepatobiliary disorders       
Cholecystitis acute * 1  1/188 (0.53%)  1 0/7 (0.00%)  0 0/5 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5.00%
Adults (Group 1) Adolescents (Group 2) Children (Group 3)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   139/188 (73.94%)      6/7 (85.71%)      3/5 (60.00%)    
Gastrointestinal disorders       
Stomatitis * 1  1/188 (0.53%)  1 1/7 (14.29%)  1 0/5 (0.00%)  0
General disorders       
Injection site Pain  1  139/188 (73.94%)  139 6/7 (85.71%)  6 3/5 (60.00%)  3
Injection site Erythema  1  0/188 (0.00%)  0 0/7 (0.00%)  0 2/5 (40.00%)  2
Fever  1  2/188 (1.06%)  2 0/7 (0.00%)  0 1/5 (20.00%)  1
Malaise  1  23/188 (12.23%)  23 0/7 (0.00%)  0 0/5 (0.00%)  0
Infections and infestations       
Nasopharyngitis * 1  7/188 (3.72%)  7 0/7 (0.00%)  0 1/5 (20.00%)  1
Musculoskeletal and connective tissue disorders       
Myalgia  1  93/188 (49.47%)  93 4/7 (57.14%)  4 1/5 (20.00%)  1
Nervous system disorders       
Headache  1  14/188 (7.45%)  14 0/7 (0.00%)  0 0/5 (0.00%)  0
Indicates events were collected by systematic assessment
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 15.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
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.
Results Point of Contact
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
Responsible Party: Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier: NCT01608815     History of Changes
Other Study ID Numbers: TYP31 (SFY12079)
U1111-1124-7699 ( Other Identifier: WHO )
First Submitted: May 28, 2012
First Posted: May 31, 2012
Results First Submitted: March 7, 2014
Results First Posted: May 12, 2014
Last Update Posted: May 12, 2014