Phase IV Trial to Collect Safety Data and Sera for Immunogenicity Testing in Healthy Children Given Fluzone® Vaccine

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00561002

First received: November 19, 2007

Last updated: March 30, 2010

Last verified: March 2010

History of Changes

Results First Received: July 20, 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: 2007-2008 Influenza Virus 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
The study participants were enrolled from 29 October 2007 through 27 November 2007 at 1 US site.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 34 participants who met the inclusion and exclusion criteria were enrolled, 2 were not vaccinated and excluded from the analysis.

Reporting Groups

	Description
Influenza Vaccine Naive/Inadequately Primed	Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
Influenza Vaccine Primed	Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.

Participant Flow: Overall Study

	Influenza Vaccine Naive/Inadequately Primed	Influenza Vaccine Primed
STARTED	23	9
COMPLETED	23	9
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Influenza Vaccine Naive/Inadequately Primed	Participants had no more than one previous lifetime dose of influenza vaccine and received two doses of Fluzone®, on Days 0 and 14.
Influenza Vaccine Primed	Participants had previously received 2 injections of Influenza vaccine in the same season and received a single dose of Fluzone® on Day 0.
Total	Total of all reporting groups

Baseline Measures

	Influenza Vaccine Naive/Inadequately Primed	Influenza Vaccine Primed	Total
Number of Participants [units: participants]	23	9	32
Age [units: participants]
<=18 years	23	9	32
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: Months] Mean ± Standard Deviation
Age Continuous	19.8 ± 8.76	24.5 ± 5.10	21.2 ± 8.11
Gender [units: participants]
Female	13	4	17
Male	10	5	15
Region of Enrollment [units: participants]
United States	23	9	32

Outcome Measures

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1. Primary:

Number of Participants Who Had Solicited Injection Site and Systemic Reactions After Vaccination With Fluzone 2007-2008 Formulation [ Time Frame: Days 0-3 post-dose ]

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2. Other Pre-specified:

Geometric Mean Titers (GMTs) of Hemagglutinin Antibodies Pre- and Post-Fluzone® Vaccination [ Time Frame: Day 0 and Day 14 after last dose of Fluzone ]

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3. Other Pre-specified:

Percentage of Participants With at Least a 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination (Seroprotection) [ Time Frame: Day 14 post-vaccination ]

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4. Other Pre-specified:

Seroconversion Rates for Each Influenza Antigen Post-Vaccination [ Time Frame: Day 14 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
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:	NCT00561002 History of Changes
Other Study ID Numbers:	GRC38
Study First Received:	November 19, 2007
Results First Received:	July 20, 2009
Last Updated:	March 30, 2010
Health Authority:	United States: Food and Drug Administration

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