Immunogenicity and Safety of ADACEL™ as Fifth Dose in Taiwan

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00258908

First received: November 24, 2005

Last updated: November 18, 2009

Last verified: November 2009

History of Changes

Results First Received: April 7, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Prevention
Conditions:	Diphtheria Tetanus Pertussis
Intervention:	Biological: Diphteria, tetanus, and Acellular Pertussis vaccine

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
Study participants were enrolled from 01 November through 07 December 2005 in 1 medical clinic in Taiwan

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 115 participants that met the inclusion and exclusion criteria were recruited for the study; 112 were vaccinated and included in the final analysis and this report.

Reporting Groups

	Description
ADACEL™ Group	Participants received 1 dose of ADACEL™ (TdcP vaccine)

Participant Flow: Overall Study

	ADACEL™ Group
STARTED	112 ^[1]
COMPLETED	112
NOT COMPLETED	0

[1]	3 participants were not vaccinated and were not included in the final analysis and in this report.

Baseline Characteristics

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Reporting Groups

	Description
ADACEL™ Group	Participants received 1 dose of ADACEL™ (TdcP vaccine)

Baseline Measures

	ADACEL™ Group
Number of Participants [units: participants]	112
Age [units: participants]
<=18 years	112
Between 18 and 65 years	0
>=65 years	0
Age [units: years] Mean ± Standard Deviation	6.8 ± 0.30
Gender [units: participants]
Female	57
Male	55
Region of Enrollment [units: participants]
Taiwan	112

Outcome Measures

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1. Primary:

Percentage of Participants With Antibody (Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids) Reponses Pre- and Post-vaccination [ Time Frame: Day 0 and Day 28 Post-vaccination ]

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2. Primary:

Geometric Mean Titers (GMTs) of Anti-diphtheria, Anti-tetanus, and Anti-pertussis Toxoids Pre- and Post-vaccination [ Time Frame: Day 0 and Day 28 post-vaccination ]

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3. Secondary:

Percentage of Participants Reporting Solicited Injection Site and Systemic Reactions Post-vaccination [ Time Frame: Within 8 days of vaccination ]

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Serious Adverse Events

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Time Frame	Adverse events data were collected from day of vaccination to 28 days post-vaccination.
Additional Description	No text entered.

Reporting Groups

	Description
ADACEL™ Group	Participants received 1 dose of ADACEL™ (TdcP vaccine)

Serious Adverse Events

	ADACEL™ Group
Total, serious adverse events
# participants affected / at risk	0/112 (0.00%)

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
Not Applicable.

Results Point of Contact:

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

No publications provided

Responsible Party:	Medical Director, Sanofi Pasteur, Inc.
ClinicalTrials.gov Identifier:	NCT00258908 History of Changes
Other Study ID Numbers:	TD521
Study First Received:	November 24, 2005
Results First Received:	April 7, 2009
Last Updated:	November 18, 2009
Health Authority:	Taiwan: Department of Health

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