Non-Inferiority of Various GSK Bio's Influenza Vaccine Presentations in Adults Aged 65 Years and Over

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00532298

First received: September 19, 2007

Last updated: April 23, 2012

Last verified: April 2012

History of Changes

Results First Received: April 23, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Influenza Infection
Interventions:	Biological: GSK Bio's influenza vaccine GSK576389A [NH 2006/07 season] Biological: GSK Bio's influenza vaccine GSK576389A [NH 2007/08 season] Biological: Fluarix [NH 2006/07 season] Biological: Fluarix [NH 2007/08 season]

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
Two subjects enrolled in this study were not vaccinated and as such not accounted for under Started.

Reporting Groups

	Description
GSK576389A- 2006/2007 Season - 1 Container Group	Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
GSK576389A - 2006/2007 Season - 2 Containers Group	Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
Fluarix 2006/2007 Season Group	Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
GSK576389A - 2007/2008 Season - 1 Container Group	Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
GSK576389A - 2007/2008 Season - 2 Containers Group	Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
Fluarix 2007/2008 Season Group	Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.

Participant Flow: Overall Study

	GSK576389A- 2006/2007 Season - 1 Container Group	GSK576389A - 2006/2007 Season - 2 Containers Group	Fluarix 2006/2007 Season Group	GSK576389A - 2007/2008 Season - 1 Container Group	GSK576389A - 2007/2008 Season - 2 Containers Group	Fluarix 2007/2008 Season Group
STARTED	269	266	264	264	268	263
COMPLETED	267	265	263	264	267	261
NOT COMPLETED	2	1	1	0	1	2
Adverse Event	1	0	0	0	1	1
Lost to Follow-up	1	1	1	0	0	1

Baseline Characteristics

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Reporting Groups

	Description
GSK576389A- 2006/2007 Season - 1 Container Group	Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
GSK576389A - 2006/2007 Season - 2 Containers Group	Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
Fluarix 2006/2007 Season Group	Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
GSK576389A - 2007/2008 Season - 1 Container Group	Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
GSK576389A - 2007/2008 Season - 2 Containers Group	Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
Fluarix 2007/2008 Season Group	Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.
Total	Total of all reporting groups

Baseline Measures

	GSK576389A- 2006/2007 Season - 1 Container Group	GSK576389A - 2006/2007 Season - 2 Containers Group	Fluarix 2006/2007 Season Group	GSK576389A - 2007/2008 Season - 1 Container Group	GSK576389A - 2007/2008 Season - 2 Containers Group	Fluarix 2007/2008 Season Group	Total
Number of Participants [units: participants]	269	266	264	264	268	263	1594
Age [units: Years] Mean ± Standard Deviation
Years	73.2 ± 5.56	73.0 ± 5.16	72.8 ± 5.06	73.3 ± 5.86	73.2 ± 5.72	73.0 ± 5.20	73.08 ± 5.43
Gender [units: Subjects]
Female	151	149	150	145	152	153	900
Male	118	117	114	119	116	110	694

Outcome Measures

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1. Primary:

Haemagglutination Inhibition (HI) Antibody Titers for the H1N1 Vaccine Strain [ Time Frame: At Days 0 and 21 ]

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2. Secondary:

HI Antibody Titers Against Each of the Three Vaccine Strains for the Two Season Formulations [ Time Frame: At Days 0 and 21 ]

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3. Secondary:

The Number of Subjects Seroconverted for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations [ Time Frame: At Day 21 ]

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4. Secondary:

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

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5. Secondary:

The Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Strains for the Two Season Formulations [ Time Frame: At Days 0 and 21 ]

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6. 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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7. Secondary:

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

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8. 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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9. Secondary:

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

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10. 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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11. Secondary:

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

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12. Secondary:

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) [ Time Frame: During a 21-day follow-up period (Day 0-20) after vaccination ]

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Serious Adverse Events

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Other Adverse Events

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Time Frame	Serious adverse events were assessed from day 0 to day 20. Systematically assessed frequent adverse events (AEs) and non-systematically assesed frequent AEs were assessed during 7 day and 21 day post vaccination period respectively.
Additional Description	For the systematically assessed other (non-serious) adverse events, the number of participants at risk included those from Total Vaccinated cohort who had the symptom sheet completed.

Frequency Threshold

Threshold above which other adverse events are reported	5%

Reporting Groups

	Description
GSK576389A- 2006/2007 Season - 1 Container Group	Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 1 container.
GSK576389A - 2006/2007 Season - 2 Containers Group	Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2006/2007 influenza season presented in 2 containers.
Fluarix 2006/2007 Season Group	Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2006-2007 influenza season.
GSK576389A - 2007/2008 Season - 1 Container Group	Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 1 container.
GSK576389A - 2007/2008 Season - 2 Containers Group	Subjects aged ≥ 65 years received adjuvanted influenza vaccine GSK576389A for the Northern Hemisphere 2007/2008 influenza season presented in 2 containers.
Fluarix 2007/2008 Season Group	Subjects aged ≥ 65 years received a single dose of Fluarix vaccine formulation recommended for the Northern Hemisphere 2007-2008 influenza season.

Other Adverse Events

	GSK576389A- 2006/2007 Season - 1 Container Group	GSK576389A - 2006/2007 Season - 2 Containers Group	Fluarix 2006/2007 Season Group	GSK576389A - 2007/2008 Season - 1 Container Group	GSK576389A - 2007/2008 Season - 2 Containers Group	Fluarix 2007/2008 Season Group
Total, other (not including serious) adverse events
# participants affected / at risk	165/269	146/266	59/264	148/264	144/268	51/263
General disorders
Pain ^†
# participants affected / at risk	165/268 (61.57%)	146/265 (55.09%)	47/263 (17.87%)	148/263 (56.27%)	144/268 (53.73%)	37/261 (14.18%)
Redness ^†
# participants affected / at risk	113/268 (42.16%)	131/265 (49.43%)	59/263 (22.43%)	108/263 (41.06%)	120/268 (44.78%)	51/261 (19.54%)
Swelling ^†
# participants affected / at risk	52/268 (19.40%)	53/265 (20.00%)	13/263 (4.94%)	53/263 (20.15%)	49/268 (18.28%)	18/261 (6.90%)
Arthralgia ^†
# participants affected / at risk	58/268 (21.64%)	36/265 (13.58%)	19/263 (7.22%)	39/264 (14.77%)	30/267 (11.24%)	20/261 (7.66%)
Fatigue ^†
# participants affected / at risk	89/268 (33.21%)	90/265 (33.96%)	39/263 (14.83%)	83/264 (31.44%)	82/267 (30.71%)	33/261 (12.64%)
Headache ^†
# participants affected / at risk	76/268 (28.36%)	67/265 (25.28%)	26/263 (9.89%)	62/264 (23.48%)	58/267 (21.72%)	27/261 (10.34%)
Myalgia ^†
# participants affected / at risk	85/268 (31.72%)	63/265 (23.77%)	25/263 (9.51%)	75/264 (28.41%)	77/267 (28.84%)	29/261 (11.11%)
Nausea ^†
# participants affected / at risk	22/268 (8.21%)	25/265 (9.43%)	14/263 (5.32%)	26/264 (9.85%)	18/267 (6.74%)	10/261 (3.83%)
Shivering ^†
# participants affected / at risk	46/268 (17.16%)	25/265 (9.43%)	6/263 (2.28%)	45/264 (17.05%)	25/267 (9.36%)	6/261 (2.30%)
Injection site pruritus ^*
# participants affected / at risk	12/269 (4.46%)	14/266 (5.26%)	7/264 (2.65%)	13/264 (4.92%)	15/268 (5.60%)	5/263 (1.90%)

†	Events were collected by systematic assessment
*	Events were collected by non-systematic assessment

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:	NCT00532298 History of Changes
Other Study ID Numbers:	110620
Study First Received:	September 19, 2007
Results First Received:	April 23, 2012
Last Updated:	April 23, 2012
Health Authority:	Denmark: Danish Medicines Agency

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