A Study to Assess the Safety of Adacel® Vaccine

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT01040052

First received: December 21, 2009

Last updated: March 1, 2011

Last verified: March 2011

History of Changes

Results First Received: March 1, 2011

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Prevention
Conditions:	Diphtheria Tetanus Pertussis
Intervention:	Biological: Adacel® (Tetanus, Reduced Diphtheria Toxoid and Acellular Pertussis)

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
Participants were enrolled from 06 to 13 December 2009 in 1 medical center in Vietnam.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 30 participants who met the inclusion and exclusion criteria were enrolled, vaccinated, and evaluated.

Reporting Groups

	Description
ADACEL® Vaccine Group	All participants received a single dose of ADACEL® vaccine on Day 0.

Participant Flow: Overall Study

	ADACEL® Vaccine Group
STARTED	30
COMPLETED	30
NOT COMPLETED	0

Baseline Characteristics

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Reporting Groups

	Description
ADACEL® Vaccine Group	All participants received a single dose of ADACEL® vaccine on Day 0.

Baseline Measures

	ADACEL® Vaccine Group
Number of Participants [units: participants]	30
Age [units: participants]
<=18 years	0
Between 18 and 65 years	30
>=65 years	0
Age [units: Years] Mean ± Standard Deviation	35.1 ± 5.82
Gender [units: participants]
Female	12
Male	18
Region of Enrollment [units: participants]
Vietnam	30

Outcome Measures

1. Primary:

Number of Participants Reporting at Least One Solicited Local or Systemic Reaction Post-Vaccination With ADACEL® Vaccine [ Time Frame: Days 0-7 Post-vaccination ]

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Serious Adverse Events

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Other Adverse Events

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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

Limitations and Caveats

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.

Results Point of Contact:

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

No publications provided

Responsible Party:	Medical Monitor, Sanofi Pasteur Inc.
ClinicalTrials.gov Identifier:	NCT01040052 History of Changes
Other Study ID Numbers:	TD532, U1111-1111-6093
Study First Received:	December 21, 2009
Results First Received:	March 1, 2011
Last Updated:	March 1, 2011
Health Authority:	Vietnam: Ministry of Health

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