Immunogenicity and Safety Study to Evaluate Different Formulations of GSK Biologicals' Influenza Vaccine GSK576389A
Information source: GlaxoSmithKline
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Influenza
Intervention: GlaxoSmithKline Biologicals' influenza vaccine GSK576389A (Biological); Fluarix (Biological)
Phase: Phase 2
Status: Completed
Sponsored by: GlaxoSmithKline Official(s) and/or principal investigator(s): GSK Clinical Trials, Study Director, Affiliation: GlaxoSmithKline
Summary
In order to find the formulation leading to a maximal increase of the immune response while
maintaining an acceptable safety profile, this study is designed to evaluate the
immunogenicity, safety and reactogenicity of the different formulations of GSK Biologicals'
influenza vaccine administered in adults aged 65 years and older compared to Fluarix.
Clinical Details
Official title: Observer Blind Immunogenicity and Safety Study of GlaxoSmithKline Biologicals' Influenza Vaccine GSK576389A With Various Formulations in Adults Aged 65 Years and Above
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention
Primary outcome: Haemagglutination Inhibition (HI) Antibody Titers
Secondary outcome: HI Antibody Titers at Day 0 and Day 21HI Antibody Titers at Day 180 The Number of Subjects Seroconverted to HI Antibodies at Day 21 The Number of Subjects Seroconverted to HI Antibodies at Day 180 HI Antibody Seroconversion Factors at Day 21 HI Antibody Seroconversion Factors at Day 180 The Number of Subjects Seroprotected to HI Antibodies at Day 0 and 21 The Number of Subjects Seroprotected to HI Antibodies at Day 180 The Geometric Mean (GM) Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21 The GM Number of Influenza-specific CD4 T-cells Per Million CD4+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180 The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Days 0 and 21 The GM Number of Influenza-specific CD8 T-cells Per Million CD8+ T-cells for Each Vaccine Strain Producing at Least Two Different Immune Markers or Producing Each of the Immune Markers Plus Another Immune Marker at Day 180 Number of Subjects Reporting Any and Grade 3 Solicited Local Adverse Events (AEs) Duration of Solicited Local AEs Number of Subjects Reporting Any, Grade 3 and Related Solicited General AEs Duration of Solicited General AEs Number of Subjects Reporting Any, Grade 3 and Related Unsolicited AEs Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 0 and Day 20 Number of Subjects Reporting Any, Grade 3 and Related Adverse Events Resulting in Medically Attended Visit Between Day 21 and Day 179 Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 0 and Day 20 Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs) Between Day 21 and Day 179
Detailed description:
There are 10 parallel groups: 9 observer blinded groups with subjects 65 years and older
receiving an investigational vaccine or Fluarix, and 1 open group with subjects between 18
and 40 years old receiving Fluarix. CMI response will be determined for a subset only.
The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep
2007.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects who the investigator believes that they can and will comply with the
requirements of the protocol should be enrolled in the study.
- A male or female aged 18-40 years old or 65 years or older at the time of the
vaccination.
- Written informed consent obtained from the subject.
- Free of an acute aggravation of the health status as established by clinical
evaluation (medical history and medical history directed examination) before entering
into the study.
- If the subject is female, she must be of non-childbearing potential or if she is of
childbearing potential, she must practice adequate contraception for 30 days prior to
vaccination, have a negative pregnancy test and continue such precautions 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(s) within 30 days prior to vaccination, or planned use 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 during the
entire study period.
- Planned administration of an influenza vaccine other than the study vaccines during
the entire study period.
- Vaccination against influenza since January 2007 (with 2007/2008 or 2006/2007
influenza vaccine).
- Administration of more than 14 days of immunosuppressants or other immune-modifying
drugs within 6 months prior to the administration of the study vaccine.
- Any confirmed or suspected immunosuppressive or immunodeficient condition, based on
medical history and physical examination
- Hypersensitivity to a previous dose of influenza vaccine.
- Allergy to any component of the vaccine.
- Acute (active) clinically significant pulmonary, cardiovascular, hepatic or renal
functional abnormality.
- Acute disease at the time of enrolment. (Acute disease is defined as the presence of
a moderate or severe illness with or without fever. All vaccines can be administered
to persons with a minor illness such as diarrhoea, mild upper respiratory infection
with or without low-grade febrile illness, i. e. axillary temperature<37. 5ºC (99. 5ºF).
- Administration of immunoglobulins and/or any blood products within the three months
preceding the first administration of the study vaccine or planned administration
during the study.
- Any medical conditions in which IM injections are contraindicated.
- Lactating female or female planning to become pregnant or to discontinue
contraceptive precautions
Locations and Contacts
GSK Investigational Site, Berlin 10435, Germany
GSK Investigational Site, Berlin 12627, Germany
GSK Investigational Site, Berlin 13347, Germany
GSK Investigational Site, Berlin 13359, Germany
GSK Investigational Site, Hamburg 22335, Germany
GSK Investigational Site, Hamburg 22415, Germany
GSK Investigational Site, Rotterdam 3015 GE, Netherlands
GSK Investigational Site, Rotterdam 3011 EN, Netherlands
GSK Investigational Site, Eskilstuna SE-631 88, Sweden
GSK Investigational Site, Karlskrona SE-371 41, Sweden
GSK Investigational Site, Uppsala SE-751 85, Sweden
GSK Investigational Site, Clydebank, Glasgow G81 2DR, United Kingdom
GSK Investigational Site, Edgbaston, Birmingham B15 2SQ, United Kingdom
GSK Investigational Site, Waterloo, Liverpool L22 0LG, United Kingdom
GSK Investigational Site, Gueglingen, Baden-Wuerttemberg 74363, Germany
GSK Investigational Site, Mannheim, Baden-Wuerttemberg 68161, Germany
GSK Investigational Site, Rudersberg, Baden-Wuerttemberg 73635, Germany
GSK Investigational Site, Weinheim, Baden-Wuerttemberg 69469, Germany
GSK Investigational Site, Augsburg, Bayern 86150, Germany
GSK Investigational Site, Reading, Berkshire RG2 0TG, United Kingdom
GSK Investigational Site, Buckshaw Village, Chorley, Lancashire PR7 7NA, United Kingdom
GSK Investigational Site, Essen, Nordrhein-Westfalen 45359, Germany
GSK Investigational Site, Koeln, Nordrhein-Westfalen 51069, Germany
GSK Investigational Site, Mainz, Rheinland-Pfalz 55131, Germany
GSK Investigational Site, Rhaunen, Rheinland-Pfalz 55624, Germany
GSK Investigational Site, Dresden, Sachsen 01067, Germany
GSK Investigational Site, Freital, Sachsen 01705, Germany
GSK Investigational Site, Leipzig, Sachsen 04103, Germany
GSK Investigational Site, Magdeburg, Sachsen-Anhalt 39112, Germany
GSK Investigational Site, Wolmirstedt, Sachsen-Anhalt 39326, Germany
Additional Information
Starting date: October 2007
Last updated: November 8, 2012
|