Immunogenicity and Safety Study to Evaluate Different Formulations of GSK Biologicals' Influenza Vaccine GSK576389A

NCT ID: NCT00540592

Last Updated: 2018-06-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 2007 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-08
• Study Completion Date: 2008-06-10

Brief 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.

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.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Influenza vaccine GSK576389A formulation 1 Group

Subjects aged ≥65 years received one dose of formulation 1 of the adjuvanted influenza vaccine GSK576389A.

Group Type: EXPERIMENTAL

GlaxoSmithKline Biologicals' influenza vaccine GSK576389A

Intervention Type: BIOLOGICAL

Single dose, Intramuscular injection, 8 different formulations were tested (one per group)

Influenza vaccine GSK576389A formulation 2 Group

Subjects aged ≥65 years received one dose of formulation 2 of the adjuvanted influenza vaccine GSK576389A.

Group Type: EXPERIMENTAL

GlaxoSmithKline Biologicals' influenza vaccine GSK576389A

Intervention Type: BIOLOGICAL

Single dose, Intramuscular injection, 8 different formulations were tested (one per group)

Influenza vaccine GSK576389A formulation 3 Group

Subjects aged ≥65 years received one dose of formulation 3 of the adjuvanted influenza vaccine GSK576389A.

Group Type: EXPERIMENTAL

GlaxoSmithKline Biologicals' influenza vaccine GSK576389A

Intervention Type: BIOLOGICAL

Single dose, Intramuscular injection, 8 different formulations were tested (one per group)

Influenza vaccine GSK576389A formulation 4 Group

Subjects aged ≥65 years received one dose of formulation 4 of the adjuvanted influenza vaccine GSK576389A.

Group Type: EXPERIMENTAL

GlaxoSmithKline Biologicals' influenza vaccine GSK576389A

Intervention Type: BIOLOGICAL

Single dose, Intramuscular injection, 8 different formulations were tested (one per group)

Influenza vaccine GSK576389A formulation 5 Group

Subjects aged ≥65 years received one dose of formulation 5 of the adjuvanted influenza vaccine GSK576389A.

Group Type: EXPERIMENTAL

GlaxoSmithKline Biologicals' influenza vaccine GSK576389A

Intervention Type: BIOLOGICAL

Single dose, Intramuscular injection, 8 different formulations were tested (one per group)

Influenza vaccine GSK576389A formulation 6 Group

Subjects aged ≥65 years received one dose of formulation 6 of the adjuvanted influenza vaccine GSK576389A.

Group Type: EXPERIMENTAL

GlaxoSmithKline Biologicals' influenza vaccine GSK576389A

Intervention Type: BIOLOGICAL

Single dose, Intramuscular injection, 8 different formulations were tested (one per group)

Influenza vaccine GSK576389A formulation 7 Group

Subjects aged ≥65 years received one dose of formulation 7 of the adjuvanted influenza vaccine GSK576389A.

Group Type: EXPERIMENTAL

GlaxoSmithKline Biologicals' influenza vaccine GSK576389A

Intervention Type: BIOLOGICAL

Single dose, Intramuscular injection, 8 different formulations were tested (one per group)

Influenza vaccine GSK576389A formulation 8 Group

Subjects aged ≥65 years received one dose of formulation 8 of the adjuvanted influenza vaccine GSK576389A.

Group Type: EXPERIMENTAL

GlaxoSmithKline Biologicals' influenza vaccine GSK576389A

Intervention Type: BIOLOGICAL

Single dose, Intramuscular injection, 8 different formulations were tested (one per group)

Fluarix elderly Group

Subjects aged ≥65 years received one dose of Fluarix vaccine.

Group Type: ACTIVE_COMPARATOR

Fluarix

Intervention Type: BIOLOGICAL

Single dose, Intramuscular injection

Fluarix young Group

Subjects aged 18-40 years received one dose of Fluarix vaccine.

Group Type: ACTIVE_COMPARATOR

Fluarix

Intervention Type: BIOLOGICAL

Single dose, Intramuscular injection

Interventions

GlaxoSmithKline Biologicals' influenza vaccine GSK576389A

Single dose, Intramuscular injection, 8 different formulations were tested (one per group)

Intervention Type: BIOLOGICAL

Fluarix

Single dose, Intramuscular injection

Intervention Type: BIOLOGICAL

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Güglingen, Baden-Wurttemberg, Germany

GSK Investigational Site

Mannheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Rudersberg, Baden-Wurttemberg, Germany

GSK Investigational Site

Weinheim, Baden-Wurttemberg, Germany

GSK Investigational Site

Augsburg, Bavaria, Germany

GSK Investigational Site

Cologne, North Rhine-Westphalia, Germany

GSK Investigational Site

Essen, North Rhine-Westphalia, Germany

GSK Investigational Site

Mainz, Rhineland-Palatinate, Germany

GSK Investigational Site

Rhaunen, Rhineland-Palatinate, Germany

GSK Investigational Site

Dresden, Saxony, Germany

GSK Investigational Site

Freital, Saxony, Germany

GSK Investigational Site

Leipzig, Saxony, Germany

GSK Investigational Site

Magdeburg, Saxony-Anhalt, Germany

GSK Investigational Site

Wolmirstedt, Saxony-Anhalt, Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Berlin, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Hamburg, , Germany

GSK Investigational Site

Rotterdam, , Netherlands

GSK Investigational Site

Rotterdam, , Netherlands

GSK Investigational Site

Eskilstuna, , Sweden

GSK Investigational Site

Karlskrona, , Sweden

GSK Investigational Site

Uppsala, , Sweden

GSK Investigational Site

Reading, Berkshire, United Kingdom

GSK Investigational Site

Buckshaw Village, Chorley, Lancashire, United Kingdom

GSK Investigational Site

Clydebank, Glasgow, , United Kingdom

GSK Investigational Site

Edgbaston, Birmingham, , United Kingdom

GSK Investigational Site

Waterloo, Liverpool, , United Kingdom

Countries

Germany; Netherlands; Sweden; United Kingdom

References

Rumke HC, Richardus JH, Rombo L, Pauksens K, Plassmann G, Durand C, Devaster JM, Dewe W, Oostvogels L. Selection of an adjuvant for seasonal influenza vaccine in elderly people: modelling immunogenicity from a randomized trial. BMC Infect Dis. 2013 Jul 26;13:348. doi: 10.1186/1471-2334-13-348.

Reference Type: DERIVED

PMID: 23890405 (View on PubMed)

Study Documents

Document Type: Annotated Case Report Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Informed Consent Form

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Statistical Analysis Plan

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Clinical Study Report

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Individual Participant Data Set

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Dataset Specification

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Document Type: Study Protocol

For additional information about this study please refer to the GSK Clinical Study Register

View Document

Related Links

https://www.clinicalstudydatarequest.com

Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Other Identifiers

110847

Identifier Type: -

Identifier Source: org_study_id