Safety and Immunogenicity of DAPTACEL® as 5th Dose in Children 4 to 6 Years Old After 4 Doses of Pentacel™ or DAPTACEL®

This study has been completed.

Study NCT00258895 Information provided by Sanofi-Aventis

First Received on November 24, 2005. Last Updated on April 28, 2010 History of Changes

Results First Received: August 18, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Conditions:	Diphtheria Tetanus Pertussis
Intervention:	Biological: DAPTACEL®: DTaP

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 30 March 2005 to 02 March 2006 at 22 US sites.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 649 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Reporting Groups

	Description
DAPTACEL®-Primed	Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
Pentacel®-Primed	Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.

Participant Flow: Overall Study

	DAPTACEL®-Primed	Pentacel®-Primed
STARTED	487	162
COMPLETED	477	159
NOT COMPLETED	10	3
Lost to Follow-up	3	1
Protocol Violation	6	2
Withdrawal by Subject	1	0

Baseline Characteristics

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Reporting Groups

	Description
DAPTACEL®-Primed	Participants received Daptacel in Study P3T06; and a fifth dose of DAPTACEL® vaccine concurrently with a fourth dose of inactivated poliovirus vaccine in this study.
Pentacel®-Primed	Participants received Pentacel in Study P3T06, received a fifth dose of DAPTACEL® vaccine after 4 doses of Pentacel® vaccine in this study.

Baseline Measures

	DAPTACEL®-Primed	Pentacel®-Primed	Total
Number of Participants [units: participants]	487	162	649
Age [units: participants]
<=18 years	487	162	649
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: Years] Mean ± Standard Deviation	4.1 ± 0.14	4.1 ± 0.16	4.1 ± 0.14
Gender [units: participants]
Female	244	83	327
Male	243	79	322
Region of Enrollment [units: participants]
United States	487	162	649

Outcome Measures

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1. Primary:

Percentage of Participants Reporting Solicited Local or Systemic Reactions Post-Dose 5 of DAPTACEL® Vaccination [ Time Frame: 0 to 7 days Post-Dose 5 ]

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2. Primary:

Percentage of Participants With Anti-Pertussis 4-Fold Rises Post-Dose 5 of DAPTACEL® Vaccination [ Time Frame: Day 28 to 48 Post-dose 5 ]

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3. Primary:

Percentage of Participants With Anti-Pertussis Booster Response Post-Dose 5 of DAPTACEL® Vaccination [ Time Frame: Day 28 to 48 Post-Dose 5 ]

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4. Primary:

Percentage of Participants With Anti-Diphtheria and Anti-Tetanus Toxoids Responses Pre- and Post-Dose 5 of DAPTACEL® Vaccination. [ Time Frame: Day 0 and between Days 28-48 Post-dose 5 ]

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5. Primary:

Geometric Mean Titers (GMTs) of Anti-Pertussis, Anti-Diphtheria, and Anti-Tetanus Toxoids Pre- and Post-dose 5 of DAPTACEL® Vaccination [ Time Frame: Day 0 and between Days 28-48 post-dose 5 ]

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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 Director, Sanofi Pasteur Inc
ClinicalTrials.gov Identifier:	NCT00258895 History of Changes
Other Study ID Numbers:	P3T11
Study First Received:	November 24, 2005
Results First Received:	August 18, 2009
Last Updated:	April 28, 2010
Health Authority:	United States: Food and Drug Administration