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

NCT01160237 | Terminated Phase 3 Results

• 1 other identifier: 114454
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 5

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

Keywords

H1N1; Pandemrix; Fluarix; Influenza

Outcome Measures

Primary Outcomes (1)

• Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies for Each Vaccine Strain, in Subjects Aged 18-60 and Above 60 Years

  21 days after vaccination

Secondary Outcomes (5)

• Solicited Local and General Symptoms

  During 7 days (Day 0 - Day 6) after vaccination

• Number of Subjects Reporting Unsolicited Adverse Events

  During 31 days (Day 0 - Day 30) after vaccination

• Number of Subjects Reporting Serious Adverse Events

  During the whole study period (Day 0 - Day 182)

• Potential Immune Mediated Diseases

  During the whole study period (Day 0 - Day 182)

• Humoral Immune Response in Terms of HI Antibodies Against Each Vaccine Strain, at Different Timepoints in Subjects Aged 18-60 and Above 60 Years

  At Days 0, 7 and 182

Study Arms (3)

Group A

EXPERIMENTAL

Subjects previously vaccinated with a vaccine against the pandemic H1N1 strain

Biological: PandemrixTM

Group B

EXPERIMENTAL

Subjects previously vaccinated with a vaccine against the pandemic H1N1 strain

Biological: FluarixTM/ Influsplit SSW® 2010/2011

Group C

ACTIVE COMPARATOR

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

Biological: FluarixTM/ Influsplit SSW® 2010/2011

Interventions

PandemrixTM BIOLOGICAL

One dose intramuscular injection

Group A

FluarixTM/ Influsplit SSW® 2010/2011 BIOLOGICAL

One dose intramuscular injection

Group B; Group C

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (5)

GSK Investigational Site

Tübingen, Baden-Wurttemberg, 72074, Germany

Location

GSK Investigational Site

Würzburg, Bavaria, 97070, Germany

Location

GSK Investigational Site

Goch, North Rhine-Westphalia, 47574, Germany

Location

GSK Investigational Site

Mainz, Rhineland-Palatinate, 55131, Germany

Location

GSK Investigational Site

Leipzig, Saxony, 04103, Germany

Location

Related Links

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

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Limitations and Caveats

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

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2010
• First Posted: July 12, 2010
• Study Start: August 1, 2010
• Primary Completion: February 1, 2011
• Study Completion: February 1, 2011
• Last Updated: October 20, 2016
• Results First Posted: March 23, 2012

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will share

Locations

DE (5)