Safety and Immunogenicity of Fluzone® Vaccine in Children Who Received 2 Doses of the 2005-2006 Fluzone Formulation.

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00390884

First received: October 20, 2006

Last updated: January 4, 2010

Last verified: January 2010

History of Changes

Results First Received: September 21, 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, Fluzone®

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 into this study from 03 October 2006 to 04 January 2007 at 5 US clinical centers.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 173 participants were enrolled, vaccinated, and analyzed.

Reporting Groups

	Description
Fluzone®-Primed Group	Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
Fluzone®-Naive Group	Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.

Participant Flow: Overall Study

	Fluzone®-Primed Group	Fluzone®-Naive Group
STARTED	116	57
COMPLETED	114	55
NOT COMPLETED	2	2
Withdrawal by Subject	2	2

Baseline Characteristics

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Reporting Groups

	Description
Fluzone®-Primed Group	Participants had received two doses of the 2005-2006 formulation of Fluzone® vaccine in the fall of 2005 (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
Fluzone®-Naive Group	Participants had never received influenza vaccine and had received two doses of placebo (Study GRC28 NCT00242424); they received two doses of Fluzone® Pediatric 2006-2007 formulation.
Total	Total of all reporting groups

Baseline Measures

	Fluzone®-Primed Group	Fluzone®-Naive Group	Total
Number of Participants [units: participants]	116	57	173
Age [units: participants]
<=18 years	116	57	173
Between 18 and 65 years	0	0	0
>=65 years	0	0	0
Age [units: Months] Mean ± Standard Deviation	13.8 ± 1.01	13.9 ± 1.13	13.8 ± 1.07
Gender [units: participants]
Female	48	22	70
Male	68	35	103
Region of Enrollment [units: participants]
United States	116	57	173

Outcome Measures

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1. Primary:

Percentage of Seroprotected Participants Post-vaccination With Fluzone® [ Time Frame: Day 28 Post-vaccination ]

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2. Secondary:

Geometric Mean Titers (GMTs) of Hemagglutination Inhibition Antibodies Post-vaccination With Fluzone® [ Time Frame: Day 28 Post-vaccination ]

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3. Other Pre-specified:

Percentage of Participants With At Least One Solicited Injection Site or Systemic Reaction Post-vaccination With Fluzone® [ Time Frame: Days 0-7 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:	NCT00390884 History of Changes
Other Study ID Numbers:	GRC29
Study First Received:	October 20, 2006
Results First Received:	September 21, 2009
Last Updated:	January 4, 2010
Health Authority:	United States: Food and Drug Administration

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