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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 21

HI 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

Page last updated: August 20, 2015

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