Study to Evaluate the Immune Response and the Safety of Fluarix TM/ Influsplit SSW® 2010/2011 or Pandemrix TM

This study has been terminated.

(The study was terminated for logistic reasons not related to safety or efficacy of the vaccine.)

Sponsor:

Information provided by:

GlaxoSmithKline

ClinicalTrials.gov Identifier:

NCT01160237

First received: July 8, 2010

Last updated: February 21, 2012

Last verified: February 2012

History of Changes

Results First Received: February 21, 2012

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Efficacy Study; Intervention Model: Parallel Assignment; Masking: Open Label; Primary Purpose: Prevention
Condition:	Influenza Infection
Interventions:	Biological: Pandemrix™ Biological: Fluarix™/ Influsplit SSW® 2010/2011

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
Pandemrix Group	Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
Fluarix Group	Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
Control Group	Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.

Participant Flow: Overall Study

	Pandemrix Group	Fluarix Group
STARTED	4	3
COMPLETED	4	3
NOT COMPLETED	0	0

Baseline Characteristics

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Reporting Groups

	Description
Pandemrix Group	Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
Fluarix Group	Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
Control Group	Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
Total	Total of all reporting groups

Baseline Measures

	Pandemrix Group	Fluarix Group	Control Group	Total
Number of Participants [units: participants]	4	3	0	7
Age [units: years] Mean ± Standard Deviation	61.3 ± 9.50	55.3 ± 18.80		58.7 ± 13.16
Gender [units: subjects]
Female	3	2		5
Male	1	1		2

Outcome Measures

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1. Primary:

Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies for Each Vaccine Strain, in Subjects Aged 18-60 and Above 60 Years [ Time Frame: 21 days after vaccination ]

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2. Secondary:

Solicited Local and General Symptoms [ Time Frame: During 7 days (Day 0 - Day 6) after vaccination ]

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3. Secondary:

Number of Subjects Reporting Unsolicited Adverse Events [ Time Frame: During 31 days (Day 0 - Day 30) after vaccination ]

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4. Secondary:

Number of Subjects Reporting Serious Adverse Events [ Time Frame: During the whole study period (Day 0 - Day 182) ]

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5. Secondary:

Potential Immune Mediated Diseases [ Time Frame: During the whole study period (Day 0 - Day 182) ]

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6. Secondary:

Humoral Immune Response in Terms of HI Antibodies Against Each Vaccine Strain, at Different Timepoints in Subjects Aged 18-60 and Above 60 Years [ Time Frame: At Days 0, 7 and 182 ]

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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
Only 7 subjects were enrolled in either the Pandemrix Group or the Fluarix Group and none in the Control Group since the study was terminated prematurely. Therefore most outcome measures (except unsolicited AEs and SAEs) were not analysed.

Results Point of Contact:

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

No publications provided

Responsible Party:	Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier:	NCT01160237 History of Changes
Other Study ID Numbers:	114454
Study First Received:	July 8, 2010
Results First Received:	February 21, 2012
Last Updated:	February 21, 2012
Health Authority:	Germany: Paul-Ehrlich-Institut

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