Persistence of Bactericidal Antibodies in Adolescents and Adults Who Had Received a Single Dose of Menactra® Vaccine

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00862277

First received: March 13, 2009

Last updated: January 12, 2011

Last verified: January 2011

History of Changes

Results First Received: December 11, 2010

Study Type:	Observational
Study Design:	Observational Model: Case Control; Time Perspective: Retrospective
Conditions:	Meningococcal Infections Meningitis

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 16 December 2008 to 16 March 2009 in 21 medical centers in the US.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 763 participants who met the inclusion and exclusion criteria were enrolled. One participant withdrew before sampling and is excluded from analysis and this report.

Reporting Groups

	Description
Group 1: Menactra® From Previous Studies	Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
Group 2: Menomune® From Previous Study	Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
Group 3: Control	Meningococcal vaccine-naive, age-matched participants

Participant Flow: Overall Study

	Group 1: Menactra® From Previous Studies	Group 2: Menomune® From Previous Study	Group 3: Control
STARTED	561	96	105
COMPLETED	560	94	100
NOT COMPLETED	1	2	5
Protocol Violation	1	2	5

Baseline Characteristics

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Reporting Groups

	Description
Group 1: Menactra® From Previous Studies	Participants who previously received only 1 dose of meningococcal vaccine, Menactra®, in Study MTA04, MTA12, MTA19, or MTA21
Group 2: Menomune® From Previous Study	Participants who previously received only one dose of meningococcal vaccine, Menomune®, in Study MTA04
Group 3: Control	Meningococcal vaccine-naive, age-matched participants
Total	Total of all reporting groups

Baseline Measures

	Group 1: Menactra® From Previous Studies	Group 2: Menomune® From Previous Study	Group 3: Control	Total
Number of Participants [units: participants]	561	96	105	762
Age [units: participants]
<=18 years	205	0	57	262
Between 18 and 65 years	356	96	48	500
>=65 years	0	0	0	0
Age [units: Years] Mean ± Standard Deviation	19.1 ± 2.87	23.3 ± 2.17	19.3 ± 3.98	19.7 ± 3.27
Gender [units: participants]
Female	264	49	64	377
Male	297	47	41	385
Region of Enrollment [units: participants]
United States	561	96	105	762

Outcome Measures

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1. Primary:

Percentage of Participants With Serum Bactericidal Antibody Titers for Meningococcal Serogroups A, C, Y, and W-135 at ≥ 8 and ≥ 128 at Enrollment [ Time Frame: Day 0 ]

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2. Primary:

Geometric Mean Titers of Serum Bactericidal Antibody Assay Using Baby Rabbit Complement (SBA-BR) at Enrollment [ Time Frame: Day 0 ]

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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:	NCT00862277 History of Changes
Other Study ID Numbers:	MTA64
Study First Received:	March 13, 2009
Results First Received:	December 11, 2010
Last Updated:	January 12, 2011
Health Authority:	United States: Food and Drug Administration

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