Study to Evaluate the Immunogenicity and Safety of 2 Formulations of GlaxoSmithKline (GSK) Biologicals' GSK1247446A Low Dose Influenza Vaccine Candidate

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00374842

First received: September 8, 2006

Last updated: March 7, 2013

Last verified: February 2013

History of Changes

Results First Received: March 7, 2013

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Single Blind (Subject); Primary Purpose: Prevention
Condition:	Influenza
Interventions:	Biological: Fluarix™ Biological: GSK1247446A

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
A total of 300 subjects were enrolled in the study. Study duration was of approximately 1 month (30 days) for all subjects.

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
GSK1247446A Formulation 1 Group	Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
GSK1247446A Formulation 2 Group	Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Fluarix Group	Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.

Participant Flow: Overall Study

	GSK1247446A Formulation 1 Group	GSK1247446A Formulation 2 Group	Fluarix Group
STARTED	100	100	100
COMPLETED	100	100	100
NOT COMPLETED	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
GSK1247446A Formulation 1 Group	Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a full dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
GSK1247446A Formulation 2 Group	Subjects aged 18 - 59 years at the time of enrolment received one dose of the GSK1247446A vaccine adjuvanted with a half dose of adjuvant at Day 0. The adjuvanted GSK1247446A vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Fluarix Group	Subjects aged 18 - 59 years at the time of enrolment received one dose of the Fluarix™ vaccine at Day 0. The Fluarix™ vaccine was administered intramuscularly in the deltoid region of the non-dominant arm.
Total	Total of all reporting groups

Baseline Measures

	GSK1247446A Formulation 1 Group	GSK1247446A Formulation 2 Group	Fluarix Group	Total
Number of Participants [units: participants]	100	100	100	300
Age [units: Years] Mean ± Standard Deviation	37.3 ± 13.94	35.0 ± 13.26	37.7 ± 13.75	36.7 ± 13.65
Gender [units: Participants]
Female	65	60	57	182
Male	35	40	43	118

Outcome Measures

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1. Primary:

Titers of Serum Haemagglutination-inhibition (HI) Antibodies Against Each of the 3 Influenza Strains Assessed. [ Time Frame: At Day 0 and at Day 21. ]

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2. Primary:

Number of Seroprotected Subjects Against Each of the 3 Influenza Strains Assessed. [ Time Frame: At Day 0 and at Day 21. ]

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3. Primary:

Number of Seroconverted Subjects Against Each of the 3 Influenza Strains Assessed [ Time Frame: At Day 21. ]

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4. Primary:

Seroconversion Factor Against Each of the 3 Influenza Strains Assessed. [ Time Frame: At Day 21. ]

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5. Secondary:

Number of Subjects With Any and Grade 3 Solicited Local Symptoms [ Time Frame: Within the 7-day follow-up period (Days 0-6) after vaccination ]

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6. Secondary:

Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: Within the 7-day follow-up period (Days 0-6) after vaccination ]

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7. Secondary:

Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: Within the 30-day follow-up period (Days 0-29) after vaccination ]

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8. Secondary:

Number of Subjects With Any and Related Serious Adverse Events (SAEs) [ Time Frame: From study start to study end, from Day 0 to Day 30 ]

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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:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00374842 History of Changes
Other Study ID Numbers:	108656
Study First Received:	September 8, 2006
Results First Received:	March 7, 2013
Last Updated:	March 7, 2013
Health Authority:	Belgium: The Federal Public Service (FPS) Health, Food Chain Safety and Environment

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