Study to Demonstrate the Lot-to-lot Consistency and to Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate

May 9, 2018 updated by: GlaxoSmithKline

Demonstrate the Lot-to-lot Consistency of 3 Consecutive Production Lots of an Adjuvanted Influenza Vaccine Candidate and Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate Versus Fluarix™ Administered Intramuscularly in Elderly

The purpose of this phase IIb study is to demonstrate the consistency of three lots of an adjuvanted influenza vaccine candidate and to evaluate the safety of this vaccine compared to Fluarix™ administered intramuscularly in elderly aged 60 years old and above.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Study Type

Interventional

Enrollment (Actual)

3124

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Estonia
      • Tartu, Estonia, 50417
        • GSK Investigational Site
  • France
      • Caen cedex 4, France, 14052
        • GSK Investigational Site
      • Gières, France, 38610
        • GSK Investigational Site
      • Lagord, France, 17140
        • GSK Investigational Site
      • Lille, France, 59019
        • GSK Investigational Site
      • Montpellier Cedex 5, France, 34295
        • GSK Investigational Site
      • Paris, France, 75679
        • GSK Investigational Site
      • Poitiers, France, 86000
        • GSK Investigational Site
      • Rouen, France, 76100
        • GSK Investigational Site
      • Toulouse, France, 31300
        • GSK Investigational Site
  • Germany
    • Bayern
      • Haag, Bayern, Germany, 83527
        • GSK Investigational Site
      • Hoehenkirchen-Siegertsbrunn, Bayern, Germany, 85635
        • GSK Investigational Site
      • Marktl, Bayern, Germany, 84533
        • GSK Investigational Site
      • Oberaudorf, Bayern, Germany, 83080
        • GSK Investigational Site
    • Brandenburg
      • Ketzin, Brandenburg, Germany, 14669
        • GSK Investigational Site
    • Niedersachsen
      • Koenigslutter, Niedersachsen, Germany, 38154
        • GSK Investigational Site
      • Tostedt, Niedersachsen, Germany, 21255
        • GSK Investigational Site
    • Sachsen
      • Delitzsch, Sachsen, Germany, 04509
        • GSK Investigational Site
      • Freital, Sachsen, Germany, 01705
        • GSK Investigational Site
      • Kamenz, Sachsen, Germany, 01917
        • GSK Investigational Site
      • Pirna, Sachsen, Germany, 01796
        • GSK Investigational Site
      • Weissenberg, Sachsen, Germany, 02627
        • GSK Investigational Site
    • Sachsen-Anhalt
      • Wolmirstedt, Sachsen-Anhalt, Germany, 39326
        • GSK Investigational Site
    • Schleswig-Holstein
      • Bad Bramstedt, Schleswig-Holstein, Germany, 24576
        • GSK Investigational Site
  • Greece
      • Athens, Greece, 11527
        • GSK Investigational Site
      • Goudi / Athens, Greece, 115 27
        • GSK Investigational Site
      • Haidari, Greece, 124 62
        • GSK Investigational Site
      • Marousi, Greece, 151 26
        • GSK Investigational Site
      • Nikaia Piraeus, Greece, 184 54
        • GSK Investigational Site
      • Orestiada, Greece, 682 00
        • GSK Investigational Site
      • Papagos/Athens, Greece, 15669
        • GSK Investigational Site
      • Thessaloniki, Greece, 54642
        • GSK Investigational Site
  • Norway
      • Elverum, Norway, 2408
        • GSK Investigational Site
      • Hamar, Norway, 2317
        • GSK Investigational Site
      • Paradis, Norway, 5231
        • GSK Investigational Site
      • Stavanger, Norway, 4010
        • GSK Investigational Site
  • Russian Federation
      • Ekaterinburg, Russian Federation, 620078
        • GSK Investigational Site
      • Kazan, Russian Federation, 420015
        • GSK Investigational Site
      • Saratov, Russian Federation, 410018
        • GSK Investigational Site
  • United Kingdom
      • Edgbaston, Birmingham, United Kingdom, B15 2SQ
        • GSK Investigational Site
      • Manchester, United Kingdom, M15 6SX
        • GSK Investigational Site
      • Waterloo, Liverpool, United Kingdom, L22 0LG
        • GSK Investigational Site
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG2 7AG
        • GSK Investigational Site
    • Glamorgan
      • Cardiff, Glamorgan, United Kingdom, CF14 5GJ
        • GSK Investigational Site
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G81 4SA
        • GSK Investigational Site
    • Lancashire
      • Buckshaw Village, Chorley, Lancashire, United Kingdom, PR7 7NA
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • A male or female age 60 years or older at the time of the vaccination.
  • Subjects who the investigator believes can and will comply with the requirements of the protocol
  • Written informed consent obtained from the subject.
  • Free of an acute aggravation of the health status as established by clinical examination before entering into the study.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) within 30 days preceding the administration of the study vaccine, or planned use during the study period.
  • Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within three months prior to the first vaccine dose.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination
  • Administration of immunoglobulins and/or any blood products within the 3 months preceding the first dose of study vaccine or planned administration during the study period.
  • Administration of other licensed vaccines within 2 weeks (for inactivated vaccines) or 4 weeks (for live vaccines) prior to enrolment in this study. Planned administration of a vaccine not foreseen by the study protocol up to 30 days after vaccination.
  • History of hypersensitivity to a previous dose of influenza vaccine.
  • History of confirmed influenza infection within the last 12 months.
  • History of allergy or reactions likely to be exacerbated by any component of the vaccine(s)
  • Acute disease at the time of enrolment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: GSK1247446A Lot 1 Group
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations
Single dose, Intramuscular injection
Experimental: GSK1247446A Lot 2 Group
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 2 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations
Single dose, Intramuscular injection
Experimental: GSK1247446A Lot 3 Group
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 3 GSK1247446A vaccine adjuvanted with AS03 at Day 0. The vaccine was administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations
Single dose, Intramuscular injection
Experimental: GSK1247446A Pooled Group
Subjects aged 60 years or older at the time of vaccination received 1 dose of Lot 1, 2 or 3 GSK1247446A vaccines adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations
Single dose, Intramuscular injection
Active Comparator: Fluarix Group
Subjects aged 60 years or older at the time of vaccination received 1 dose of FluarixTM vaccine adjuvanted with AS03 at Day 0. The vaccines were administered intramuscularly into the deltoid region of the non-dominant arm.
Biological: Fluarix TM
Single dose, Intramuscular injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Titers for Serum Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Time Frame: At Days 0 and 21
Titers are presented as geometric mean titers (GMTs). The 3 influenza strains assessed were A/New Caledonia, A/New York and B/Malaysia. The seropositivity cut-off assay was 1:10. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.
At Days 0 and 21
Number of Seroconverted Subjects Against 3 Strains of Influenza Disease.
Time Frame: At Day 21
A seroconverted subject was defined as a vaccinated subject who had either a pre-vaccination titer <1:10 and a post-vaccination titer ≥1:40 or a pre-vaccination titer ≥1:10 and at least a four-fold increase in post-vaccination titer. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.
At Day 21
Number of Seroprotected Subjects Against 3 Strains of Influenza Disease.
Time Frame: At Days 0 and 21
A seroprotected subject was defined as a vaccinated subject who had a serum HI titer ≥ 1:40. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.
At Days 0 and 21
Seroconversion Factor for Hemagglutination Inhibition (HI) Antibodies Against 3 Strains of Influenza Disease.
Time Frame: At Day 21
The seroconversion factor (SCF) was defined as the fold increase in serum Hemagglutination Inhibition (HI) geometric mean titers (GMTs) post vaccination compared to Day 0. The 3 assessed influenza strains were A/New Caledonia, A/New York and B/Malaysia. The results for the GSK1247446A Lot 1, 2, 3 and Pooled Groups are the primary efficacy variables.
At Day 21
Number of Subjects With Any, Grade 3 and Related Solicited Local Symptoms.
Time Frame: During the 7-day (Days 0-6) post vaccination period
Assessed solicited local symptoms were ecchymosis, pain, redness and swelling at injection site. Any = incidence of a particular symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling/ecchymosis = redness/swelling/ecchymosis spreading beyond 50 millimeters (mm) of the injection site. All solicited local symptoms were assessed by the investigator as being related to study vaccination.
During the 7-day (Days 0-6) post vaccination period
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms.
Time Frame: During the 7-day (Days 0-6) post vaccination period
Assessed solicited general symptoms were arthralgia, fatigue, fever [oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)], headache, muscle aches and shivering. Any = incidence of a particular symptom regardless of grade intensity or relationship with the study vaccination. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever > 39.0°C. Related = symptom considered by the investigator to have a causal relationship to study vaccination.
During the 7-day (Days 0-6) post vaccination period
Number of Subjects With New Onset of Chronic Diseases (NOCDs).
Time Frame: From Day 0 to Day 180
NOCDs include conditions such as diabetes, autoimmune disease, asthma, allergies etc. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the NOCDs.
From Day 0 to Day 180
Number of Subjects With Medically Significant Conditions (MSCs).
Time Frame: From Day 0 to Day 180
MSCs were defined as conditions prompting emergency room visits or physician visits that were not related to common diseases or routine visits. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the MSCs.
From Day 0 to Day 180
Number of Subjects With Any, Grade 3 and Related Unsolicited Adverse Events (AEs).
Time Frame: During the 30-day (Days 0-29) post-vaccination period
Unsolicited AE covers any AE reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms. Any = any unsolicited AE regardless of intensity or relationship to vaccination. Grade 3 = unsolicited AE that prevented normal activity Related = unsolicited AE assessed by the investigator as related to the vaccination. This table includes rare events, defined as events with an occurrence rate of 0.1 % and belonging to the AEs.
During the 30-day (Days 0-29) post-vaccination period
Number of Subjects With Any and Related Serious Adverse Events (SAEs).
Time Frame: During the entire study period (Days 0-180)
SAEs assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization, result in disability/incapacity or are a congenital anomaly/birth defect in the offspring of a study subject. Any = any SAE regardless of intensity or relationship to vaccination. Related (REL) = SAE assessed by the investigator as related to the vaccination.
During the entire study period (Days 0-180)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

GlaxoSmithKline

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 27, 2006

Primary Completion (Actual)

July 1, 2006

Study Completion (Actual)

July 7, 2006

Study Registration Dates

First Submitted

May 3, 2006

First Submitted That Met QC Criteria

May 3, 2006

First Posted (Estimate)

May 4, 2006

Study Record Updates

Last Update Posted (Actual)

June 8, 2018

Last Update Submitted That Met QC Criteria

May 9, 2018

Last Verified

September 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 107192
  • 107214 (Other Identifier: GSK)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Study Protocol
    Information identifier: 107192
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Individual Participant Data Set
    Information identifier: 107192
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Dataset Specification
    Information identifier: 107192
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Clinical Study Report
    Information identifier: 107192
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Informed Consent Form
    Information identifier: 107192
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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