Evaluation of Safety and Immunogenicity of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Years and Older

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00760617

First received: September 25, 2008

Last updated: October 4, 2012

Last verified: September 2012

History of Changes

Results First Received: March 29, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Conditions:	Influenza Disease Influenza Vaccines
Interventions:	Biological: GSK Bio's influenza vaccine GSK2186877A Biological: Fluarix

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
New Generation Influenza Vaccine GSK2186877A Group	Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
Fluarix Elderly Group	Subjects aged ≥65 years received 1 dose of Fluarix vaccine
Fluarix Young Group	Subjects aged 18-40 years received 1 dose of Fluarix vaccine

Participant Flow: Overall Study

	New Generation Influenza Vaccine GSK2186877A Group	Fluarix Elderly Group	Fluarix Young Group
STARTED	266	144	116
COMPLETED	261	142	111
NOT COMPLETED	5	2	5
Adverse Event	5	2	0
Lost to Follow-up	0	0	5

Baseline Characteristics

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Reporting Groups

	Description
New Generation Influenza Vaccine GSK2186877A Group	Subjects aged ≥65 years received 1 dose of New generation influenza vaccine GSK2186877A
Fluarix Elderly Group	Subjects aged ≥65 years received 1 dose of Fluarix vaccine
Fluarix Young Group	Subjects aged 18-40 years received 1 dose of Fluarix vaccine
Total	Total of all reporting groups

Baseline Measures

	New Generation Influenza Vaccine GSK2186877A Group	Fluarix Elderly Group	Fluarix Young Group	Total
Number of Participants [units: participants]	266	144	116	526
Age [units: Years] Mean ± Standard Deviation	73.5 ± 5.27	73.8 ± 5.54	28.2 ± 6.34	63.59 ± 19.65
Gender [units: subjects]
Female	143	68	53	264
Male	123	76	63	262

Outcome Measures

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1. Primary:

Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) [ Time Frame: Day 0-6 ]

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2. Primary:

Duration of Solicited Local AEs [ Time Frame: Day 0-6 ]

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3. Primary:

Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs [ Time Frame: Day 0-6 ]

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4. Primary:

Duration of Solicited General AEs [ Time Frame: Day 0-6 ]

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5. Primary:

Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs [ Time Frame: Day 0-20 ]

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6. Primary:

Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 0 to 20 [ Time Frame: Day 0-20 ]

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7. Primary:

Number of Subjects Reporting Any, Grade 3 and Related AEs With a Medically Attended Visit Between Day 21 to 179 [ Time Frame: Day 21-179 ]

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8. Primary:

Number of Subjects Reporting AEs of Specific Interest (AESI) Including Autoimmune Disease (AID) [ Time Frame: Day 0-179 ]

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9. Primary:

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

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10. Primary:

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 to Day 179 [ Time Frame: Day 21-179 ]

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11. Primary:

Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) From Day 180 to Day 209 [ Time Frame: Day 180 to Day 209 ]

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12. Secondary:

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

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13. Secondary:

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

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14. Secondary:

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

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15. Secondary:

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

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16. Secondary:

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

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17. Secondary:

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

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18. Secondary:

HI Antibody Seroconversion Factor (SCF) at Day 21 [ Time Frame: Day 21 ]

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19. Secondary:

HI Antibody SCF at Day 180 [ Time Frame: Day 180 ]

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20. Secondary:

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

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21. Secondary:

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

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22. Secondary:

The Geometric Mean (GM) Number of Influenza Specific Cluster of Differentiation 4 (CD4) T-cells Per Million CD4 T-cells for Each Vaccine Strain Expressing at Least Two Different Markers or Expressing Different Combinations of Markers at Days 0 and 21 [ Time Frame: At Day 0 and 21 ]

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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:	NCT00760617 History of Changes
Other Study ID Numbers:	111737
Study First Received:	September 25, 2008
Results First Received:	March 29, 2012
Last Updated:	October 4, 2012
Health Authority:	Netherlands: Ministry of Health, Welfare and Sports Germany: Paul-Ehrlich-Institut Sweden: Medical Products Agency

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