Study of Inactivated, Split-Virion Influenza Vaccine Compared With Standard Fluzone Vaccine in Elderly Subjects

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT00388583

First received: October 16, 2006

Last updated: April 13, 2012

Last verified: April 2012

History of Changes

Results First Received: July 14, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Conditions:	Orthomyxoviridae Infection Influenza Myxovirus Infection
Intervention:	Biological: Split, Inactivated, Trivalent Influenza 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
Participants were enrolled from 28 September 2006 through 30 May 2007 in 16 clinics 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 816 of the 817 participants that met the inclusion and exclusion criteria were enrolled and vaccinated. Data on the 807 participants that completed the study are presented.

Reporting Groups

	Description
Fluzone Intradermal (ID) Vaccine Group	Participants received a dose of Fluzone Intradermal vaccine on Day 0
Fluzone Intramuscular (IM) Vaccine Group	Participants received a dose of Fluzone Intramuscular vaccine on Day 0

Participant Flow: Overall Study

	Fluzone Intradermal (ID) Vaccine Group	Fluzone Intramuscular (IM) Vaccine Group
STARTED	407	410
COMPLETED	401	406
NOT COMPLETED	6	4
Protocol Violation	1	0
Withdrawal by Subject	3	3
Serious Adverse Event	2	0
Did not receive vaccine	0	1

Baseline Characteristics

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Reporting Groups

	Description
Fluzone ID Vaccine Group	Participants received a dose (0.1 mL) of Fluzone intradermal vaccine on Day 0.
Fluzone IM Vaccine Group	Participants received a dose (0.5 mL) of Fluzone intramuscular vaccine on Day 0.
Total	Total of all reporting groups

Baseline Measures

	Fluzone ID Vaccine Group	Fluzone IM Vaccine Group	Total
Number of Participants [units: participants]	401	406	807
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	0	0	0
>=65 years	401	406	807
Age [units: Years] Mean ± Standard Deviation	72.8 ± 6.08	72.3 ± 5.83	72.5 ± 5.955
Gender [units: participants]
Female	234	223	457
Male	167	183	350
Region of Enrollment [units: Participants]
United States	401	406	807

Outcome Measures

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1. Primary:

Number of Participants With at Least a 4-Fold Increase in Serum HAI Antibody Titer Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine. [ Time Frame: Pre-vaccination and Day 28 post-vaccination ]

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2. Primary:

Number of Participants Who Achieved Seroprotection Post-vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine. [ Time Frame: Day 28 post-vaccination ]

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3. Secondary:

Geometric Mean Antibody Titers (GMTs) Before and Post-vaccination With Either Fluzone Intradermal and Fluzone Intramuscular Vaccine. [ Time Frame: Pre- and Day 28 post-vaccination ]

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4. Secondary:

Number of Participants Reporting a Solicited Injection Site or Systemic Reaction, Post Vaccination With Either Fluzone Intradermal or Fluzone Intramuscular Vaccine [ Time Frame: Day 0 up to 7 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
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:	Sanofi
ClinicalTrials.gov Identifier:	NCT00388583 History of Changes
Other Study ID Numbers:	FID04
Study First Received:	October 16, 2006
Results First Received:	July 14, 2011
Last Updated:	April 13, 2012
Health Authority:	United States: Food and Drug Administration

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