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

NCT ID: NCT01160237

Last Updated: 2016-10-20

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-02-28

Brief Summary

The aim of this study is to evaluate the immune response and the safety of one injection of FluarixTM/ Influsplit SSW® 2010/2011 or Pandemrix TM in subjects who had received a single Pandemrix TM dose at least 6 months preceding study inclusion. Subjects never vaccinated with any H1N1 pandemic vaccine will be enrolled as control.

This Protocol Posting has been updated following Amendment of the Protocol, July 2010. The impacted section is entry criteria.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A

Subjects previously vaccinated with a vaccine against the pandemic H1N1 strain

Group Type: EXPERIMENTAL

PandemrixTM

Intervention Type: BIOLOGICAL

One dose intramuscular injection

Group B

Subjects previously vaccinated with a vaccine against the pandemic H1N1 strain

Group Type: EXPERIMENTAL

FluarixTM/ Influsplit SSW® 2010/2011

Intervention Type: BIOLOGICAL

One dose intramuscular injection

Group C

Subjects not previously vaccinated with a vaccine against the pandemic H1N1 strain

Group Type: ACTIVE_COMPARATOR

FluarixTM/ Influsplit SSW® 2010/2011

Intervention Type: BIOLOGICAL

One dose intramuscular injection

Interventions

PandemrixTM

One dose intramuscular injection

Intervention Type: BIOLOGICAL

FluarixTM/ Influsplit SSW® 2010/2011

One dose intramuscular injection

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes can and will comply with the requirements of the protocol. Specific attention should be given to the compliance potential of subjects with suspected or known drug and alcohol abuse.
• Subjects who have received one dose of Pandemrix at least 6 month before enrolment, to be enrolled in the Groups A or B OR subjects who have not been previously vaccinated with a vaccine against the pandemic H1N1 strain at all, to be enrolled in group C.
• A male or female 18 years and above at the time of enrolment.
• Written informed consent obtained from the subject.
• Healthy subjects or free of acute aggravation of the health status as established by physical examination before entering into the study.
• Female subjects of non-childbearing potential may be enrolled in the study.
• Female subjects of childbearing potential may be enrolled in the study.

Exclusion Criteria

• Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the dose of study vaccine, or planned use during the study period.
• Administration of any influenza vaccine within 6 month prior to vaccination in this study.
• Presence of evidence of substance abuse or of neurological or psychiatric diagnoses which, although stable, are deemed by the investigator to render the potential subject unable/unlikely to provide accurate safety reports.
• Presence of an axillary temperature ≥ 37.5ºC, or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
• Diagnosed with cancer, or treatment for cancer, within the past 3 years.
• Any confirmed or suspected immunosuppressive or immunodeficient condition including history of human immunodeficiency virus (HIV) infection.
• Chronic administration of immunosuppressants or other immune modifying drugs within 6 months of study enrolment or planned administration during the study period..
• Any administration of a long-acting immune-modifying drug (within 3 months before study start, or a planned administration during the study period.
• Receipt of any immunoglobulins and/or any blood products within 3 months of study enrolment or planned administration of any of these products during the study period.
• Any significant disorder of coagulation or treatment with warfarin derivatives or heparin. Persons receiving individual doses of low molecular weight heparin outside of 24 hours prior to vaccination are eligible. Persons receiving prophylactic antiplatelet medications, e.g., low-dose aspirin, and without a clinically-apparent bleeding tendency, are eligible.
• An acute evolving neurological disorder or history of Guillain-Barré syndrome.
• Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
• Administration of any vaccines within 30 days before vaccination.
• Any known or suspected allergy to any constituent of influenza vaccines; a history of anaphylactic-type reaction to any constituent of influenza vaccines; or a history of severe adverse reaction to a previous influenza vaccine.
• Pregnant or lactating female
• Female planning to become pregnant or planning to discontinue contraceptive precautions from study inclusion up to 2 months after completion of the vaccination series.
• Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Tübingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Würzburg, Bavaria, Germany

GSK Investigational Site

Goch, North Rhine-Westphalia, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

Countries

Germany

Study Documents

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

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Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

114454

Identifier Type: -

Identifier Source: org_study_id