Phase IV Trial to Determine the Safety and Immunogenicity of the WHO Formulation of the 2006-2007 Fluzone® Vaccine

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00389532

First received: October 18, 2006

Last updated: September 14, 2009

Last verified: September 2009

History of Changes

Results First Received: February 24, 2009

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Influenza
Intervention:	Biological: Influenza Virus Vaccine (2006-2007 Fluzone® 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 October through December 2006 in 1 medical clinic 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 116 participants that met the inclusion and exclusion criteria were enrolled and vaccinated.

Reporting Groups

	Description
Aged 18 to 59 Years	Participants aged 18 to 59 years at enrollment
Aged ≥ 60 Years	Participants aged 60 years and older at enrollment

Participant Flow: Overall Study

	Aged 18 to 59 Years	Aged ≥ 60 Years
STARTED	60	56
COMPLETED	60 ^[1]	56
NOT COMPLETED	0	0

[1]	3 of the participants did not have valid post-vaccination serological results

Baseline Characteristics

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Reporting Groups

	Description
Aged 18 to 59 Years	Participants aged 18 to 59 years at enrollment
Aged ≥ 60 Years	Participants aged 60 years and older at enrollment
Total	Total of all reporting groups

Baseline Measures

	Aged 18 to 59 Years	Aged ≥ 60 Years	Total
Number of Participants [units: participants]	60	56	116
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	60	9	69
>=65 years	0	47	47
Age [units: years] Mean ± Standard Deviation	39.5 ± 12.25	76.4 ± 8.55	57.3 ± 21.33
Gender [units: participants]
Female	49	37	86
Male	11	19	30
Region of Enrollment [units: participants]
United States	60	56	116

Outcome Measures

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1. Primary:

Percentage of Participants With Solicited Injection Site or Systemic Reaction(s) After Fluzone® Vaccination [ Time Frame: 0-3 days post-vaccination ]

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2. Primary:

Geometric Mean Titers (GMTs) of Serum Hemagglutinnation Inhibition Antibodies Pre-vaccination and Post-vaccination [ Time Frame: 21 days 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
Not Applicable.

Results Point of Contact:

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

No publications provided

Responsible Party:	Study Director, Sanofi Pasteur Inc.
ClinicalTrials.gov Identifier:	NCT00389532 History of Changes
Other Study ID Numbers:	GRC35
Study First Received:	October 18, 2006
Results First Received:	February 24, 2009
Last Updated:	September 14, 2009
Health Authority:	United States: Food and Drug Administration

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