Safety and Immunogenicity of Trivalent Subunit Influenza Vaccine Produced in Mammalian Cell Culture Using the Strain Composition 2007/2008

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

Novartis ( Novartis Vaccines )

ClinicalTrials.gov Identifier:

NCT00511914

First received: August 3, 2007

Last updated: January 18, 2013

Last verified: January 2013

History of Changes

Results First Received: December 10, 2012

Study Type:	Interventional
Study Design:	Endpoint Classification: Safety/Efficacy Study; Intervention Model: Single Group Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Seasonal Influenza Vaccine
Intervention:	Biological: cTIV

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
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
cTIV (Adults)	Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
cTIV (Elderly)	Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).

Participant Flow: Overall Study

	cTIV (Adults)	cTIV (Elderly)
STARTED	68	67
COMPLETED	68	67
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
cTIV (Adults)	Adults 18-60 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
cTIV (Elderly)	Elderly subjects >= 61 years of age received one dose of cell culture derived trivalent influenza vaccine (cTIV).
Total	Total of all reporting groups

Baseline Measures

	cTIV (Adults)	cTIV (Elderly)	Total
Number of Participants [units: participants]	68	67	135
Age [units: years] Mean ± Standard Deviation	37.4 ± 12.3	67.4 ± 4.7	52.3 ± 17.7
Gender [units: Subjects]
Female	39	25	64
Male	29	42	71

Outcome Measures

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1. Primary:

Geometric Mean Titers (GMT) After 1 Dose of Cell Culture Derived Vaccine (cTIV). [ Time Frame: 3 weeks postvaccination (Day 22) ]

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2. Primary:

Geometric Mean Ratio After 1 Dose of the Cell Culture Derived Vaccine (cTIV) [ Time Frame: 3 weeks postvaccination (Day 22) ]

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3. Primary:

Percentages of Subjects With HI Titer ≥40 After 1 Dose of Cell Culture Derived Vaccine (cTIV). [ Time Frame: 3 weeks postvaccination (Day 22) ]

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4. Primary:

Percentages of Subjects With Seroconversion or Significant Increase After 1 Dose of Cell Culture Derived Vaccine (cTIV). [ Time Frame: 3 weeks postvaccination (Day 22) ]

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5. Secondary:

Number of Subjects Reporting Local and Systemic Reactions [ Time Frame: 3 days postvaccination ]

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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.

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
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Results Point of Contact:

Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
e-mail: RegistryContactVaccinesUS@novartis.com

No publications provided

Responsible Party:	Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:	NCT00511914 History of Changes
Other Study ID Numbers:	V58P1S, 2007-001404-20
Study First Received:	August 3, 2007
Results First Received:	December 10, 2012
Last Updated:	January 18, 2013
Health Authority:	Germany: Paul-Ehrlich-Institute

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