A Study to Demonstrate the Efficacy of GSK Biologicals' I... | NCT00363870

Studies
A Study to Demonstrate the Efficacy of GSK Biologicals' Influenza Vaccine in Adults

NCT00363870

Sponsor

GlaxoSmithKline

Status

Completed

Last Update Posted

Mar 23, 2017Actual

Enrollment

7,632

Phase

Phase 4

Conditions

Influenza

Interventions

Fluarix vaccine

Countries

Czechia
Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 2006

Primary Completion Date

Jun 2007Actual

Completion Date

Jun 2007Actual

First Submitted Date

Aug 10, 2006

First Submission Date that Met QC Criteria

Aug 10, 2006

First Posted Date

Aug 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 21, 2017

Last Update Posted Date

Mar 23, 2017Actual

Description Module

Brief Summary

The purpose of this study is to demonstrate the efficacy of GSK Biologicals' influenza vaccine (Fluarix™) administered intramuscularly in adults.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

7,632

Name	Type	Description	Arm Group Labels	Other Names
Fluarix vaccine	Biological

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
occurrence of confirmed influenza

Secondary Outcomes

Measure	Description	Time Frame
occurrence of influenza like illness
Occurrence of pneumonia
Immune response at days 0 and 21

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

A male or female age between 18 and 64 years at the time of the first vaccination.
non-childbearing female

Exclusion Criteria:

Use of non-registered products
Pregnancy
Hypersensitivity to a previous dose of influenza vaccine
Acute disease at the time of enrolment/vaccination.
History of allergy or reactions likely to be exacerbated by any component of the vaccine
Administration of any other influenza vaccine for the season 2006-2007
Chronic disorders of the pulmonary or cardiovascular system, including asthma.
Administration of immune-modifying drugs
Administration of immunoglobulins and/or any blood products
History of requiring regular medical follow-up or hospitalization during the preceding year because of chronic metabolic diseases (including diabetes mellitus), renal dysfunction, hemoglobinopathies, asthma or immunosuppression (including immunosuppression caused by medications or by human immunodeficiency virus)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

64 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
GSK Clinical Trials	GlaxoSmithKline	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Hradec Králové		500 03	Czechia
GSK Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22079305	Derived	Vesikari T, Beran J, Durviaux S, Stainier I, El Idrissi M, Walravens K, Devaster JM. Use of real-time polymerase chain reaction (rtPCR) as a diagnostic tool for influenza infection in a vaccine efficacy trial. J Clin Virol. 2012 Jan;53(1):22-8. doi: 10.1016/j.jcv.2011.10.013. Epub 2011 Nov 11.
19909082	Derived

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections