Safety and Immunogenicity of the World Health Organization (WHO) Formulation of the 2004-2005 Fluzone® Vaccine

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00831987

First received: January 28, 2009

Last updated: April 23, 2010

Last verified: April 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: Fluzone®: Influenza virus vaccine 2004-2005 formulation

Participant Flow

Hide Participant Flow

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 06 through 16 August 2004 in 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 120 participants who met the inclusion and exclusion criteria were enrolled and vaccinated.

Reporting Groups

	Description
Fluzone® Vaccine Group - Age 18-59 Years	Participants received 1 dose of Fluzone® vaccine on Day 0.
Fluzone® Vaccine Group - Age ≥ 60 Years	Participants received 1 dose of Fluzone® vaccine on Day 0.

Participant Flow: Overall Study

	Fluzone® Vaccine Group - Age 18-59 Years	Fluzone® Vaccine Group - Age ≥ 60 Years
STARTED	60	60
COMPLETED	60	60
NOT COMPLETED	0	0

Baseline Characteristics

Hide Baseline Characteristics

Reporting Groups

	Description
Fluzone® Vaccine Group - Age 18-59 Years	Participants received 1 dose of Fluzone® vaccine on Day 0.
Fluzone® Vaccine Group - Age ≥ 60 Years	Participants received 1 dose of Fluzone® vaccine on Day 0.
Total	Total of all reporting groups

Baseline Measures

	Fluzone® Vaccine Group - Age 18-59 Years	Fluzone® Vaccine Group - Age ≥ 60 Years	Total
Number of Participants [units: participants]	60	60	120
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	60	4	64
>=65 years	0	56	56
Age [units: Years] Mean ± Standard Deviation	41.3 ± 11.1	74 ± 5.9	57.7 ± 18.7
Gender [units: participants]
Female	44	38	82
Male	16	22	38
Region of Enrollment [units: participants]
United States	60	60	120

Outcome Measures

Show All Outcome Measures

1. Primary:

Percentage of Participants With Solicited Local and Systemic Reactions After Fluzone® Vaccination [ Time Frame: 0 to 3 days post-vaccination ]

Show Outcome Measure 1

2. Primary:

Geometric Mean Titers (GMTs) of Hemagglutination Antibodies Pre- and Post-Vaccination With Fluzone® Vaccine [ Time Frame: Day 0 and Day 21 Post-Vaccination ]

Show Outcome Measure 2

3. Primary:

Percentage of Participants With at Least 40 Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination [ Time Frame: 21 Days post-vaccination ]

Show Outcome Measure 3

4. Primary:

Percentage of Participants With at Least a 4-Fold Increase in Serum Hemagglutination Inhibition Antibody Titers Post-Vaccination [ Time Frame: Day 21 post-vaccination ]

Show Outcome Measure 4

Serious Adverse Events

Show Serious Adverse Events

Other Adverse Events

Show Other Adverse Events

More Information

Hide More Information

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 Monitor, Sanofi Pasteur Inc.
ClinicalTrials.gov Identifier:	NCT00831987 History of Changes
Other Study ID Numbers:	GRC20
Study First Received:	January 28, 2009
Results First Received:	July 20, 2009
Last Updated:	April 23, 2010
Health Authority:	United States: Food and Drug Administration

To Top