Study to Evaluate the Immunogenicity and Safety of an Investigational Influenza (H1N1 Influenza Virus) Vaccine in Adults, Using Two Different Manufacturing Processes

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00992511
First received: October 8, 2009
Last updated: June 30, 2011
Last verified: June 2011
  Purpose

The objective of this study is to evaluate the immunogenicity and safety of one or two doses of GSK Biologicals' investigational influenza vaccine GSK2340272A, manufactured using two different processes, in adults aged 18 to 60 years.


Condition Intervention Phase
Influenza Infection
Biological: GSK investigational vaccine GSK2340272A
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Immunological Non-inferiority Between Two Process-manufactured Influenza Vaccines in Adults Aged 18 to 60 Years

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 [ Time Frame: Day 21 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Humoral immune response in terms of HI antibodies [ Time Frame: Days 0, 21, 42, 182, 364 ] [ Designated as safety issue: No ]
  • Humoral immune response in terms of neutralizing antibodies [ Time Frame: at Days 0, 21, 42, 182 and 364 ] [ Designated as safety issue: No ]
  • Occurrence of solicited local and general symptoms [ Time Frame: During the 7-day follow-up period after each vaccination. ] [ Designated as safety issue: No ]
  • Occurrence of unsolicited adverse events [ Time Frame: Within 21 days after the first vaccination (Day 0 - Day 20) and up to 63 days after the second vaccination for the two groups with two vaccination doses (Day 21 - Day 83) ] [ Designated as safety issue: No ]
  • Occurrence of potential Immune-Mediated-Diseases [ Time Frame: During the entire study period (up to Day 364). ] [ Designated as safety issue: No ]
  • Occurrence of serious adverse events [ Time Frame: During the entire study period (up to Day 364). ] [ Designated as safety issue: No ]

Enrollment: 300
Study Start Date: October 2009
Study Completion Date: November 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: D-INI-1D group
Subjects receiving one dose of initial process-manufactured GSK2340272A vaccine
Biological: GSK investigational vaccine GSK2340272A
One intramuscular injection of initial process-manufactured GSK2340272A vaccine
Experimental: D-INI-2D group
Subjects receiving two doses of initial process-manufactured GSK2340272A vaccine
Biological: GSK investigational vaccine GSK2340272A
Two intramuscular injections of initial process-manufactured GSK2340272A vaccine
Experimental: D-NEW-1D
Subjects receiving one dose of new process-manufactured GSK2340272A vaccine
Biological: GSK investigational vaccine GSK2340272A
One intramuscular injection of new process-manufactured GSK2340272A vaccine
Experimental: D-NEW-2D
Subjects receiving two doses of new process-manufactured GSK2340272A vaccine
Biological: GSK investigational vaccine GSK2340272A
Two intramuscular injections of new process-manufactured GSK2340272A vaccine

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • All subjects must satisfy ALL the following criteria at study entry:
  • A male or female aged 18 to 60 years of age at the time of the first vaccination.
  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol.
  • Written informed consent obtained from the subject.
  • Satisfactory baseline medical assessment by history and physical examination.
  • Access to a consistent means of telephone contact, which may be either in the home or at the workplace, land line or mobile, but NOT a pay phone or multiple-user device.
  • Female subjects of non-childbearing potential may be enrolled in the study. Female subjects of childbearing potential may be enrolled in the study, if the subject has practiced adequate contraception for 30 days prior to vaccination, and has a negative pregnancy test on the day of vaccination, and has agreed to continue adequate contraception during the entire treatment period and for 2 months after completion of the vaccination series.

Exclusion Criteria:

  • Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
  • 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 >= 37.5°C (99.5°F), or acute symptoms greater than "mild" severity on the scheduled date of first vaccination.
  • Clinically or virologically confirmed influenza infection within 6 months preceding the study start.
  • Diagnosed with cancer, or treatment for cancer, within 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.
  • 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 coumarin derivatives, other vitamin K antagonists 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 acetylsalicylic acid, and without a clinically-apparent bleeding tendency, are eligible.
  • Any contraindication to intramuscular administration of the influenza vaccines.
  • An acute evolving neurological disorder or history of Guillain-Barré syndrome.
  • 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.
  • Any conditions which, in the opinion of the investigator, prevents the subjects from participating in the study.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00992511

Locations
Germany
GSK Investigational Site
Dresden, Sachsen, Germany, 01067
GSK Investigational Site
Dresden, Sachsen, Germany, 01307
GSK Investigational Site
Freiberg, Sachsen, Germany, 09599
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: NCT00992511     History of Changes
Other Study ID Numbers: 113809
Study First Received: October 8, 2009
Last Updated: June 30, 2011
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by GlaxoSmithKline:
influenza infection
GSK Bio's influenza vaccine GSK2340272A

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 April 16, 2014