Immunogenicity and Safety Study to Evaluate Different Formulations of GSK Biologicals' Influenza Vaccine GSK576389A - Study Results

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Prevention
Condition:	Influenza
Interventions:	Biological: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A Biological: Fluarix

Participant Flow

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
Influenza Vaccine GSK576389A Formulation 1 Group	Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
Influenza Vaccine GSK576389A Formulation 2 Group	Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
Influenza Vaccine GSK576389A Formulation 3 Group	Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
Influenza Vaccine GSK576389A Formulation 4 Group	Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
Influenza Vaccine GSK576389A Formulation 5 Group	Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
Influenza Vaccine GSK576389A Formulation 6 Group	Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
Influenza Vaccine GSK576389A Formulation 7 Group	Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
Influenza Vaccine GSK576389A Formulation 8 Group	Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
Fluarix Elderly Group	Subjects aged ≥65 years received one dose of Fluarix vaccine.
Fluarix Young Group	Subjects aged 18-40 years received one dose of Fluarix vaccine.

Participant Flow: Overall Study

	Influenza Vaccine GSK576389A Formulation 1 Group	Influenza Vaccine GSK576389A Formulation 2 Group	Influenza Vaccine GSK576389A Formulation 3 Group	Influenza Vaccine GSK576389A Formulation 4 Group	Influenza Vaccine GSK576389A Formulation 5 Group	Influenza Vaccine GSK576389A Formulation 6 Group	Influenza Vaccine GSK576389A Formulation 7 Group	Influenza Vaccine GSK576389A Formulation 8 Group	Fluarix Elderly Group	Fluarix Young Group
STARTED	204	202	202	202	199	198	198	199	200	203
Completed at Day 180	200	201	197	197	195	198	196	193	198	189
COMPLETED	202	201	201	201	198	198	198	198	199	201
NOT COMPLETED	2	1	1	1	1	0	0	1	1	2
Adverse Event	0	1	0	0	1	0	0	1	1	2
Lost to Follow-up	2	0	0	0	0	0	0	0	0	0
Withdrawal by Subject	0	0	1	1	0	0	0	0	0	0

Baseline Characteristics

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Reporting Groups

	Description
Influenza Vaccine GSK576389A Formulation 1 Group	Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.
Influenza Vaccine GSK576389A Formulation 2 Group	Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.
Influenza Vaccine GSK576389A Formulation 3 Group	Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.
Influenza Vaccine GSK576389A Formulation 4 Group	Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.
Influenza Vaccine GSK576389A Formulation 5 Group	Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.
Influenza Vaccine GSK576389A Formulation 6 Group	Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.
Influenza Vaccine GSK576389A Formulation 7 Group	Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.
Influenza Vaccine GSK576389A Formulation 8 Group	Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.
Fluarix Elderly Group	Subjects aged ≥65 years received one dose of Fluarix vaccine.
Fluarix Young Group	Subjects aged 18-40 years received one dose of Fluarix vaccine.
Total	Total of all reporting groups

Baseline Measures

	Influenza Vaccine GSK576389A Formulation 1 Group	Influenza Vaccine GSK576389A Formulation 2 Group	Influenza Vaccine GSK576389A Formulation 3 Group	Influenza Vaccine GSK576389A Formulation 4 Group	Influenza Vaccine GSK576389A Formulation 5 Group	Influenza Vaccine GSK576389A Formulation 6 Group	Influenza Vaccine GSK576389A Formulation 7 Group	Influenza Vaccine GSK576389A Formulation 8 Group	Fluarix Elderly Group	Fluarix Young Group	Total
Number of Participants [units: participants]	204	202	202	202	199	198	198	199	200	203	2007
Age [units: Years] Mean ± Standard Deviation	72.7 ± 5.75	72.6 ± 5.16	72.4 ± 5.62	72.9 ± 6.09	72.6 ± 5.66	72.7 ± 5.56	72.6 ± 5.67	73.0 ± 6.03	72.7 ± 5.43	27.4 ± 6.25	68.11 ± 14.81
Gender [units: Subjects]
Female	95	109	105	100	89	102	96	95	90	103	984
Male	109	93	97	102	110	96	102	104	110	100	1023

Outcome Measures

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1. Primary:

Haemagglutination Inhibition (HI) Antibody Titers [ Time Frame: At Day 21 ]

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2. Secondary:

HI Antibody Titers at Day 0 and Day 21 [ Time Frame: At Day 0 and 21 ]

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3. Secondary:

HI Antibody Titers at Day 180 [ Time Frame: At Day 180 ]

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4. Secondary:

The Number of Subjects Seroconverted to HI Antibodies at Day 21 [ Time Frame: At Day 21 ]

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5. Secondary:

The Number of Subjects Seroconverted to HI Antibodies at Day 180 [ Time Frame: At Day 180 ]

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6. Secondary:

HI Antibody Seroconversion Factors at Day 21 [ Time Frame: At Day 21 ]

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7. Secondary:

HI Antibody Seroconversion Factors at Day 180 [ Time Frame: At Day 180 ]

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8. Secondary:

The Number of Subjects Seroprotected to HI Antibodies at Day 0 and 21 [ Time Frame: At Day 0 and 21 ]

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9. Secondary:

The Number of Subjects Seroprotected to HI Antibodies at Day 180 [ Time Frame: At Day 180 ]

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10. Secondary:

The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21 [ Time Frame: At Days 0 and 21 ]

Show Outcome Measure 10

11. Secondary:

The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180 [ Time Frame: At Day 180 ]

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12. Secondary:

The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21 [ Time Frame: At Days 0 and 21 ]

Show Outcome Measure 12

13. Secondary:

The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180 [ Time Frame: At Day 180 ]

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14. Secondary:

Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) [ Time Frame: During a 7-day follow-up period (Day 0-6) after vaccination ]

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15. Secondary:

Duration of Solicited Local AEs [ Time Frame: During a 7-day follow-up period (Day 0-6) after vaccination ]

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16. Secondary:

Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs [ Time Frame: During a 7-day follow-up period (Day 0-6) after vaccination ]

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17. Secondary:

Duration of Solicited General AEs [ Time Frame: During a 7-day follow-up period (Day 0-6) after vaccination ]

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18. Secondary:

Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs [ Time Frame: During a 21-day follow-up period (Day 0-20) after vaccination ]

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19. Secondary:

Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 0 and Day 20 [ Time Frame: Between Day 0 and Day 20 after vaccination ]

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20. Secondary:

Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 21 and Day 179 [ Time Frame: Between Day 21 and Day 179 after vaccination ]

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21. Secondary:

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 and Day 20 [ Time Frame: Between Day 0 and Day 20 after vaccination ]

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22. Secondary:

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 and Day 179 [ Time Frame: Between Day 21 and Day 179 after 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: 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:	NCT00540592 History of Changes
Other Study ID Numbers:	110847
Study First Received:	October 5, 2007
Results First Received:	April 26, 2012
Last Updated:	November 8, 2012
Health Authority:	Sweden: Medical Products Agency