Study of Fluzone® Influenza Virus Vaccine 2011-2012 Formulation (Intramuscular Route) Among Adults

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Sanofi

ClinicalTrials.gov Identifier:

NCT01430819

First received: September 7, 2011

Last updated: March 18, 2013

Last verified: March 2013

History of Changes

Results First Received: March 18, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Influenza
Interventions:	Biological: Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation Biological: Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation

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 07 September through 24 October 2011 in 6 clinic sites 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 300 participants who met the inclusion, but no exclusion criteria were enrolled and vaccinated.

Reporting Groups

	Description
Fluzone® Vaccine Group	Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation
Fluzone® High-Dose Vaccine Group	Participants received the Influenza Virus Vaccine, Fluzone® High-Dose 2011-2012 Formulation.

Participant Flow: Overall Study

	Fluzone® Vaccine Group	Fluzone® High-Dose Vaccine Group
STARTED	150	150
COMPLETED	150	150
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Fluzone® Vaccine Group	Participants received the Influenza Virus Vaccine: Fluzone® 2011-2012 Formulation.
Fluzone® High-Dose Vaccine Group	Participants received the Influenza Virus Vaccine: Fluzone® High-Dose 2011-2012 Formulation.
Total	Total of all reporting groups

Baseline Measures

	Fluzone® Vaccine Group	Fluzone® High-Dose Vaccine Group	Total
Number of Participants [units: participants]	150	150	300
Age [units: participants]
<=18 years	0	0	0
Between 18 and 65 years	0	0	0
>=65 years	150	150	300
Age [units: Months] Mean ± Standard Deviation	72.6 ± 5.8	71.6 ± 4.8	72.1 ± 5.3
Gender [units: participants]
Female	91	92	183
Male	59	58	117
Region of Enrollment [units: Participants]
United States	150	150	300

Outcome Measures

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1. Primary:

Number of Participants Reporting at Least One Solicited Injection Site or Systemic Reaction Following Vaccination With One Dose of Either Fluzone® or Fluzone® High-Dose Vaccine [ Time Frame: Day 0 to up to Day 28 post-vaccination ]

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2. Other Pre-specified:

Geometric Mean Titers of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine. [ Time Frame: Day 21 post-vaccination ]

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3. Other Pre-specified:

Number of Participants With Seroconversion Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine [ Time Frame: Day 21 post-vaccination ]

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4. Other Pre-specified:

Geometric Mean of Titer Ratios (GMTR) of Antibodies to Vaccine Antigens Before and Following Vaccination With Either Fluzone® or Fluzone® High-Dose Vaccine. [ Time Frame: Day 21 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:	NCT01430819 History of Changes
Other Study ID Numbers:	GRC48, U 1111-1120-1287
Study First Received:	September 7, 2011
Results First Received:	March 18, 2013
Last Updated:	March 18, 2013
Health Authority:	United States: Food and Drug Administration

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