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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sanofi ( Sanofi Pasteur, a Sanofi Company )
ClinicalTrials.gov Identifier:
NCT01608815
First received: May 28, 2012
Last updated: April 15, 2014
Last verified: April 2014
History of Changes
Results First Received: March 7, 2014  
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

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
The study participants were enrolled from 26 May 2012 to 31 August 2012 at 4 clinic centers in Japan.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 200 participants who met all of the inclusion and none of the exclusion criteria were vaccinated in this study.

Reporting Groups
  Description
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

Participant Flow:   Overall Study
    Adults (Group 1)   Adolescents (Group 2)   Children (Group 3)
STARTED   188   7   5 
COMPLETED   188   7   5 
NOT COMPLETED   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
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
Total Total of all reporting groups

Baseline Measures
   Adults (Group 1)   Adolescents (Group 2)   Children (Group 3)   Total 
Overall Participants Analyzed 
[Units: Participants]
 		 188   7   5   200 
Age 
[Units: Participants]
 		       
<=18 years   0   7   5   12 
Between 18 and 65 years   188   0   0   188 
>=65 years   0   0   0   0 
Age 
[Units: Years]
Mean (Standard Deviation) 		 37.2  (11.4)   15.6  (2.0)   5.2  (3.8)   35.7  (12.7) 
Gender 
[Units: Participants]
 		       
Female   72   3   1   76 
Male   116   4   4   124 
Region of Enrollment 
[Units: Participants]
 		       
Japan   188   7   5   200 


  Outcome Measures
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1.  Primary:   Number of Participants With At Least a 4-Fold Rise in Vi Antibody Titers Following Vaccination With a Typhoid Vi Polysaccharide Vaccine   [ Time Frame: Day 0 (pre-vaccination) to Day 28 (post-vaccination) ]
  Show Outcome Measure 1

2.  Secondary:   Geometric Mean Titers (GMTs) of Antibodies to Vi Antibody Before and Following Vaccination With A Typhoid Vi Polysaccharide Vaccine   [ Time Frame: Day 0 (pre-vaccination) and Day 28 post-vaccination ]
  Show Outcome Measure 2

3.  Secondary:   Geometric Mean Titer Ratios (GMTRs) of Antibodies to Vi Antibody Following Vaccination With A Typhoid Vi Polysaccharide Vaccine   [ Time Frame: Day 28 post-vaccination ]
  Show Outcome Measure 3

4.  Secondary:   Number of Participants Reporting A Solicited Injection Site or Systemic Reactions Following Vaccination With A Typhoid Vi Polysaccharide Vaccine   [ Time Frame: Day 0 up to Day 7 post-vaccination ]
  Show Outcome Measure 4


  Serious Adverse Events
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  Other Adverse Events
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  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Medical Director
Organization: Sanofi Pasteur Inc.
e-mail: RegistryContactUs@sanofipasteur.com



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 )
Study First Received: May 28, 2012
Results First Received: March 7, 2014
Last Updated: April 15, 2014