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

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00321763
First received: May 3, 2006
Last updated: November 10, 2011
Last verified: November 2011
  Purpose

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.


Condition Intervention Phase
Influenza
Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations
Biological: Fluarix TM
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Demonstrate the Lot-to-lot Consistency of 3 Consecutive Production Lots of an Adjuvanted Influenza Vaccine Candidate & Evaluate the Safety of an Adjuvanted Influenza Vaccine Candidate vs Fluarix™ Administered Intramuscularly in Elderly

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Serum haemagglutination-inhibition (HI) antibody titre, against each of the 3 vaccine influenza virus strains, in a subset of subjects of groups A, B & C [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]
  • Occurrence of rare events(adverse events), in subjects in groups A, B & C [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]
  • Occurrence, intensity and relationship to vaccination of solicited local and general signs and symptoms [ Time Frame: During a 7-day follow-up period after vaccination in each group ] [ Designated as safety issue: No ]
  • Occurrence, intensity and relationship to vaccination of unsolicited AEs [ Time Frame: During a 30 day follow-up period after vaccination in each group. ] [ Designated as safety issue: No ]
  • Occurrence and relationship to vaccination of serious adverse events [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]
  • Occurrence of new onset chronic diseases [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]
  • Occurrence of medically significant conditions prompting emergency room visits or physician visits that are not related to common diseases or routine visits [ Time Frame: During the entire study period ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Serum HI antibody titre in a subset of subjects in groups A, B & C [ Time Frame: At Days 0 and 21 ] [ Designated as safety issue: No ]

Enrollment: 3124
Study Start Date: April 2006
Study Completion Date: December 2006
Primary Completion Date: July 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations
Single dose, Intramuscular injection
Experimental: Group B Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations
Single dose, Intramuscular injection
Experimental: Group C Biological: Candidate Influenza Vaccine GSK1247446A - 3 different formulations
Single dose, Intramuscular injection
Active Comparator: Group D Biological: Fluarix TM
Single dose, Intramuscular injection

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00321763

  Hide Study Locations
Locations
Estonia
GSK Investigational Site
Tartu, Estonia, 50417
France
GSK Investigational Site
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
Germany
GSK Investigational Site
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
Ketzin, Brandenburg, Germany, 14669
GSK Investigational Site
Koenigslutter, Niedersachsen, Germany, 38154
GSK Investigational Site
Tostedt, Niedersachsen, Germany, 21255
GSK Investigational Site
Wolmirstedt, Sachsen-Anhalt, Germany, 39326
GSK Investigational Site
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
Bad Bramstedt, Schleswig-Holstein, Germany, 24576
Greece
GSK Investigational Site
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
Norway
GSK Investigational Site
Elverum, Norway, 2408
GSK Investigational Site
Hamar, Norway, 2317
GSK Investigational Site
Paradis, Norway, 5231
GSK Investigational Site
Stavanger, Norway, 4010
Russian Federation
GSK Investigational Site
Ekaterinburg, Russian Federation, 620078
GSK Investigational Site
Kazan, Russian Federation, 420015
GSK Investigational Site
Saratov, Russian Federation, 410018
United Kingdom
GSK Investigational Site
Reading, Berkshire, United Kingdom, RG2 7AG
GSK Investigational Site
Cardiff, Glamorgan, United Kingdom, CF14 5GJ
GSK Investigational Site
Glasgow, Lanarkshire, United Kingdom, G81 4SA
GSK Investigational Site
Buckshaw Village, Chorley, Lancashire, United Kingdom, PR7 7NA
GSK Investigational Site
Manchester, United Kingdom, M15 6SX
GSK Investigational Site
Waterloo, Liverpool, United Kingdom, L22 0LG
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: NCT00321763     History of Changes
Other Study ID Numbers: 107192, 107214
Study First Received: May 3, 2006
Last Updated: November 10, 2011
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by GlaxoSmithKline:
Influenza
Influenza vaccine

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on May 16, 2013