Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza Vaccine for the Elderly

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT00938392

First received: July 9, 2009

Last updated: June 7, 2012

Last verified: April 2012

History of Changes

Results First Received: April 19, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator, Outcomes Assessor); Primary Purpose: Prevention
Condition:	Influenza Infection
Interventions:	Biological: GSK investigational FluNG vaccine GSK2186877A, aged lot Biological: GSK investigational FluNG vaccine GSK2186877A, fresh lot

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 the study did not receive any vaccination, and as such are not accounted for as started.

Reporting Groups

	Description
FluNG Aged Group	Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
FluNG Fresh Group	Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).

Participant Flow: Overall Study

	FluNG Aged Group	FluNG Fresh Group
STARTED	362	362
COMPLETED	360	358
NOT COMPLETED	2	4
Adverse Event	0	1
Withdrawal by Subject	0	1
Lost to Follow-up	2	2

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
FluNG Aged Group	Subjects receiving 1 dose of an aged lot of FLU NG vaccine (GSK2186877A).
FluNG Fresh Group	Subjects receiving 1 dose of a fresh lot of FLU NG vaccine (GSK2186877A).
Total	Total of all reporting groups

Baseline Measures

	FluNG Aged Group	FluNG Fresh Group	Total
Number of Participants [units: participants]	362	362	724
Age [units: Years] Mean (Standard Deviation)
Years	73.3 (6.09)	73.5 (6.36)	73.4 (6.22)
Gender [units: Subjects]
Female	239	243	482
Male	123	119	242

Outcome Measures

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1. Primary:

Serum Haemagglutination-Inhibition (HI) Antibody Titers Against the 3 Vaccine Strains [ Time Frame: At Days 0 and 21 ]

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2. Secondary:

Number of Subjects Seropositive Against the 3 Vaccine Strains [ Time Frame: At Days 0 and 21 ]

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3. Secondary:

Number of Subjects Seroconverted for the 3 Vaccine Strains [ Time Frame: At Day 21 ]

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4. Secondary:

Seroconversion Factor for the 3 Vaccine Strains [ Time Frame: At Day 21 ]

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5. Secondary:

Number of Subjects Seroprotected for the 3 Vaccine Strains [ Time Frame: At Days 0 and 21 ]

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6. Secondary:

Number of Subjects Reporting Any and Grade 3 Solicited Local Symptoms and Any, Grade 3 and Related Solicited General Symptoms [ Time Frame: During the 7-day post-vaccination period ]

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7. Secondary:

Duration of Solicited Local and General Symptoms [ Time Frame: During the 7-day post-vaccination period ]

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8. Secondary:

Number of Subjects Reporting Any, Grade 3 and Related Unsolicited Adverse Events (AEs) [ Time Frame: During the 21-day post-vaccination period ]

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9. Secondary:

Number of Subjects Reporting Adverse Events of Specific Interest (AESI) [ Time Frame: During the 21-day post-vaccination period ]

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10. Secondary:

Number of Subjects Reporting Serious Adverse Events (SAEs) [ Time Frame: During the entire study period (up to Day 21) ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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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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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.

Results Point of Contact:

Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT00938392 History of Changes
Other Study ID Numbers:	112662
Study First Received:	July 9, 2009
Results First Received:	April 19, 2012
Last Updated:	June 7, 2012
Health Authority:	Slovakia: State Institute for Drug Control Estonia: State Agency of Medicines

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