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:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: 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.
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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
Number of Participants [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) ]

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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 ]

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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 ]

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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 ]

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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
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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:

	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.
	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.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.
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
Health Authority:	Japan: Pharmaceuticals and Medical Devices Agency

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