Immunogenicity and Safety Study of GSK Biologicals' Fluviral® (2008 - 2009 Season) in Adults Over 18 Years

This study has been completed.

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00718120

First received: July 17, 2008

Last updated: October 8, 2009

Last verified: October 2009

History of Changes

Results First Received: July 16, 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: Fluviral®

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
Fluviral Adult Group	Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
Fluviral Elderly Group	Subjects aged more than 60 years received a single dose of Fluviral® vaccine.

Participant Flow: Overall Study

	Fluviral Adult Group	Fluviral Elderly Group
STARTED	55	55
COMPLETED	55	55
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Fluviral Adult Group	Subjects aged between 18 and 60 years received a single dose of Fluviral® vaccine.
Fluviral Elderly Group	Subjects aged more than 60 years received a single dose of Fluviral® vaccine.
Total	Total of all reporting groups

Baseline Measures

	Fluviral Adult Group	Fluviral Elderly Group	Total
Number of Participants [units: participants]	55	55	110
Age [units: years] Mean ± Standard Deviation	40.1 ± 12.16	66.4 ± 4.61	53.2 ± 16.08
Gender [units: subjects]
Female	36	35	71
Male	19	20	39

Outcome Measures

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1. Primary:

Hemagglutination Inhibition (HI) Antibody Titers [ Time Frame: At Day 0 and 21 ]

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2. Primary:

Number of Seroconverted Subjects [ Time Frame: At Day 21 ]

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3. Primary:

Number of Seroprotected Subjects [ Time Frame: At Day 0 and 21 ]

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4. Primary:

Fold Increase From Baseline in Serum HI Antibody Titer [ Time Frame: At Day 21 ]

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5. Secondary:

Number of Subjects Reporting Solicited Symptoms [ Time Frame: During the 4-day (Day 0-3) post-vaccination period ]

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6. Secondary:

Number of Subjects Reporting Unsolicited Adverse Events (AE) [ Time Frame: During the 21-day (Day 0-20) post-vaccination period ]

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7. Secondary:

Number of Subjects Reporting Serious Adverse Events (SAE) [ Time Frame: During the 21-day (Day 0-20) post-vaccination period ]

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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: GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.

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: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

No publications provided

Responsible Party:	Study Director, GSK
ClinicalTrials.gov Identifier:	NCT00718120 History of Changes
Other Study ID Numbers:	110584
Study First Received:	July 17, 2008
Results First Received:	July 16, 2009
Last Updated:	October 8, 2009
Health Authority:	Canada: Health Canada

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