Safety and Immune Response of Different Pediatric Combination Vaccines.

This study has been completed.

Study NCT00255047 Information provided by Sanofi-Aventis

First Received on November 15, 2005. Last Updated on October 14, 2010 History of Changes

Results First Received: September 14, 2010

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Conditions:	Diphtheria Polio Pertussis
Interventions:	Biological: DAPTACEL®. (DTaP), IPOL®., and ActHIB®. Biological: Pentacel®: DTaP-IPV/Hib combined Biological: DTaP-IPV and ActHIB®

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 10 November 2005 through 21 September 2006 in 38 Clinics in the Untied States.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 2167 participants that met the inclusion and exclusion criteria were enrolled and vaccinated. Data on Stage I, up to the 3rd dose are presented.

Reporting Groups

	Description
Study Group 1: DAPTACEL®, IPOL®, and ActHIB®	Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
Study Group 2: Pentacel®	Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
Study Group 3: DTaP-IPV and ActHIB®	Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
Study Group 4: Pentacel®	Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.

Participant Flow: Overall Study

	Study Group 1: DAPTACEL®, IPOL®, and ActHIB®	Study Group 2: Pentacel®	Study Group 3: DTaP-IPV and ActHIB®	Study Group 4: Pentacel®
STARTED	538	535	546	548
COMPLETED	490	487	496	502
NOT COMPLETED	48	48	50	46
Serious Adverse Events	2	1	2	1
Adverse Event	0	3	2	1
Protocol Violation	13	13	16	20
Lost to Follow-up	9	8	5	6
Withdrawal by Subject	24	23	25	18

Baseline Characteristics

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Reporting Groups

	Description
Study Group 1: DAPTACEL®, IPOL®, and ActHIB®	Participants received 3 doses (0.5 mL each) of DAPTACEL®, IPOL®, and ActHIB® at Months 2, 4, and 6, respectively.
Study Group 2: Pentacel®	Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.
Study Group 3: DTaP-IPV and ActHIB®	Participants received 3 doses (0.5 mL each) of DTaP-IPV and ActHIB® at Months 2, 4, and 6, respectively.
Study Group 4: Pentacel®	Participants received 3 doses (0.5 mL each) of Pentacel® at Months 2, 4, and 6 respectively.

Baseline Measures

	Study Group 1: DAPTACEL®, IPOL®, and ActHIB®	Study Group 2: Pentacel®	Study Group 3: DTaP-IPV and ActHIB®	Study Group 4: Pentacel®	Total
Number of Participants [units: participants]	538	535	546	548	2167
Age [units: Participants]
<=18 years	538	535	546	548	2167
Between 18 and 65 years	0	0	0	0	0
>=65 years	0	0	0	0	0
Age [units: Months] Mean ± Standard Deviation	2.2 ± 0.27	2.1 ± 0.27	2.2 ± 0.27	2.1 ± 0.28	2.1 ± 0.27
Gender [units: participants]
Female	251	242	249	274	1016
Male	287	293	297	274	1151
Region of Enrollment [units: participants]
United States	538	535	546	548	2167

Outcome Measures

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1. Primary:

Percentage of Participant Responding to Pertussis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations. [ Time Frame: 30 Days post-dose 3 vaccination ]

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2. Primary:

Percentage of Participants With a Four-fold Rise in Pertusis Antigens Post-Dose 3 of Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Vaccinations (Seroconversion) [ Time Frame: 30 Days post-dose 3 vaccination ]

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3. Primary:

Geometric Mean Titers (GMTs) of Antibodies to Pentacel® or DAPTACEL®, IPOL®, and ActHIB® Antigens Post-dose 3 Vaccinations. [ Time Frame: 30 Days post-dose 3 vaccination. ]

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4. Other Pre-specified:

Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reactions Post-vaccination 3 [ Time Frame: 7 days post-vaccination 3 ]

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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:	NCT00255047 History of Changes
Other Study ID Numbers:	M5A10
Study First Received:	November 15, 2005
Results First Received:	September 14, 2010
Last Updated:	October 14, 2010
Health Authority:	United States: Food and Drug Administration