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
  Purpose

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.


Condition Intervention Phase
Influenza Infection
Biological: Pandemrix™
Biological: Fluarix™/ Influsplit SSW® 2010/2011
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Immunogenicity and Safety of FluarixTM/ Influsplit SSW® 2010/2011 or Pandemrix TM

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Solicited Local and General Symptoms [ Time Frame: During 7 days (Day 0 - Day 6) after vaccination ] [ Designated as safety issue: No ]
  • Number of Subjects Reporting Unsolicited Adverse Events [ Time Frame: During 31 days (Day 0 - Day 30) after vaccination ] [ Designated as safety issue: No ]
  • Number of Subjects Reporting Serious Adverse Events [ Time Frame: During the whole study period (Day 0 - Day 182) ] [ Designated as safety issue: No ]
  • Potential Immune Mediated Diseases [ Time Frame: During the whole study period (Day 0 - Day 182) ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 7
Study Start Date: August 2010
Study Completion Date: February 2011
Primary Completion Date: February 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Pandemrix Group
Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
Biological: Pandemrix™
One dose intramuscular injection
Experimental: Fluarix Group
Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
Biological: Fluarix™/ Influsplit SSW® 2010/2011
One dose intramuscular injection
Active Comparator: Control Group
Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
Biological: Fluarix™/ Influsplit SSW® 2010/2011
One dose intramuscular injection

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01160237

Locations
Germany
GSK Investigational Site
Mainz, Rheinland-Pfalz, Germany, 55131
GSK Investigational Site
Leipzig, Sachsen, Germany, 04103
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

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

Keywords provided by GlaxoSmithKline:
H1N1
Pandemrix
Fluarix
Influenza

ClinicalTrials.gov processed this record on October 19, 2014