Evaluate Safety & Immunogenicity of a Pandemic Influenza Vaccine (GSK1562902A) in Adults Over 60 Years of Age

NCT ID: NCT00397215

Last Updated: 2019-06-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 437 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-11-17
• Study Completion Date: 2009-09-14

Brief Summary

The present study is designed to evaluate the immunogenicity and safety of a single or double dose of the pandemic influenza candidate vaccine (GSK1562902A), administered following a two-administration schedule (21 days apart) in adults over 60 years of age. The persistence of influenza antibodies will also be evaluated 24 months after vaccination.

Detailed Description

The present study is designed to evaluate the immunogenicity and safety of a single or double dose of the candidate vaccine in healthy elderly persons. The candidate vaccine will be administered following a two-administration schedule (21 days apart) in adults over 60 years of age. The persistence of H5N1 influenza antibodies will also be evaluated up to two years after vaccination (neutralizing antibodies will only be evaluated in a subset of subjects in the adjuvanted groups). Single and double dose of H5N1 vaccine non-adjuvanted vaccine will be used as comparator.

Conditions

Influenza

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

GSK1562902A 1 Group

Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not)

Intervention Type: BIOLOGICAL

intramuscular injection

Fluarix

Intervention Type: BIOLOGICAL

Intramuscular injection. All subjects not vaccinated with an influenza vaccine for the 2006-2007 season received Fluarix NH 2006/2007 (i.e. interpandemic GSK's influenza vaccine) at least 3 weeks before administration of the first dose of H5N1 vaccine.

GSK1562902A 2 Group

Subjects aged 61 years or older at the time of first vaccination received 1 dose of GSK1562902A non-adjuvanted vaccine at Day 0. The vaccine was administered intramuscularly, in the deltoid region of the non-dominant arm.

Group Type: EXPERIMENTAL

Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not)

Intervention Type: BIOLOGICAL

intramuscular injection

Fluarix

Intervention Type: BIOLOGICAL

Intramuscular injection. All subjects not vaccinated with an influenza vaccine for the 2006-2007 season received Fluarix NH 2006/2007 (i.e. interpandemic GSK's influenza vaccine) at least 3 weeks before administration of the first dose of H5N1 vaccine.

GSK1562902A 3 Group

Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A adjuvanted vaccine at Days 0 and 21. The vaccine was administered in the deltoid region of each arm.

Group Type: EXPERIMENTAL

Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not)

Intervention Type: BIOLOGICAL

intramuscular injection

Fluarix

Intervention Type: BIOLOGICAL

Intramuscular injection. All subjects not vaccinated with an influenza vaccine for the 2006-2007 season received Fluarix NH 2006/2007 (i.e. interpandemic GSK's influenza vaccine) at least 3 weeks before administration of the first dose of H5N1 vaccine.

GSK1562902A 4 Group

Subjects aged 61 years or older at the time of first vaccination received 2 doses of GSK1562902A non-adjuvanted vaccine at Days 0 and 21. The vaccine was administered in the deltoid region of each arm.

Group Type: EXPERIMENTAL

Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not)

Intervention Type: BIOLOGICAL

intramuscular injection

Fluarix

Intervention Type: BIOLOGICAL

Intramuscular injection. All subjects not vaccinated with an influenza vaccine for the 2006-2007 season received Fluarix NH 2006/2007 (i.e. interpandemic GSK's influenza vaccine) at least 3 weeks before administration of the first dose of H5N1 vaccine.

Interventions

Pandemic influenza vaccine (GSK1562902A) (adjuvanted or not)

intramuscular injection

Intervention Type: BIOLOGICAL

Fluarix

Intramuscular injection. All subjects not vaccinated with an influenza vaccine for the 2006-2007 season received Fluarix NH 2006/2007 (i.e. interpandemic GSK's influenza vaccine) at least 3 weeks before administration of the first dose of H5N1 vaccine.

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 61 years or above at the time of the first vaccination.
• Written informed consent obtained from the subject.
• Healthy subjects or subjects with well controlled underlying disease.

Exclusion Criteria

• Administration of the licensed MF59-containing vaccines, e.g. Fluad™ or Addigrip™ or virosome-based influenza vaccines such as Inflexal V™, InfectoVac Flu™ or Invivac™ during the 2006-2007 influenza season.
• Administration of 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 the second vaccination with H5N1 vaccine.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first administration of the study vaccine.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history and physical examination (no laboratory testing required).
• History of chronic alcohol consumption and/or drug abuse.
• History of hypersensitivity to vaccines.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine (including egg and thiomersal allergy).
• Acute clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests.
• Acute disease at the time of enrolment.
• Serious chronic disease including any medically significant chronic pulmonary, cardiovascular, renal, neurological, psychiatric or metabolic disorder, as determined by medical history and physical examination.
• Administration of immunoglobulins and/or any blood products within the three months preceding the first vaccination or during the study.
• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days prior to the first vaccination, or planned use during the study period.
• Any condition which, in the opinion of the investigator, prevents the subject from participation in the study.

• Minimum Eligible Age: 60 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

Dour, , Belgium

GSK Investigational Site

Gozée, , Belgium

GSK Investigational Site

Libramont, , Belgium

GSK Investigational Site

Mont-Godinne, , Belgium

GSK Investigational Site

Sprimont, , Belgium

GSK Investigational Site

Tessenderlo, , Belgium

GSK Investigational Site

Watermael-Boitsfort, , Belgium

GSK Investigational Site

Genoa, Liguria, Italy

GSK Investigational Site

Milan, Lombardy, Italy

GSK Investigational Site

Monserrato Cagliari, Sardinia, Italy

GSK Investigational Site

Sassari, Sardinia, Italy

GSK Investigational Site

Ragusa, Sicily, Italy

Countries

Belgium; Italy

References

Gillard P, Giet D, Heijmans S, Drame M, Walravens K, Roman F. Long-term outcome of the humoral and cellular immune response of an H5N1 adjuvanted influenza vaccine in elderly persons: 2-year follow-up of a randomised open-label study. Trials. 2014 Oct 29;15:419. doi: 10.1186/1745-6215-15-419.

Reference Type: BACKGROUND

PMID: 25354581 (View on PubMed)

Heijmans S, De Meulemeester M, Reynders P, Giet D, Demanet E, Devresse PY, Icardi G, Drame M, Roman F, Gillard P. Immunogenicity profile of a 3.75-mug hemagglutinin pandemic rH5N1 split virion AS03A-adjuvanted vaccine in elderly persons: a randomized trial. J Infect Dis. 2011 Apr 15;203(8):1054-62. doi: 10.1093/infdis/jiq174.

Reference Type: BACKGROUND

PMID: 21450995 (View on PubMed)

Study Documents

Document Type: Informed Consent Form

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: Statistical Analysis Plan

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

Document Type: Dataset Specification

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. The results of this study 108251 are summarised with studies 108252, 111275, and 111276 on the GSK Clinical Study Register.

View Document

Related Links

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Other Identifiers

108252

Identifier Type: OTHER

Identifier Source: secondary_id

111275

Identifier Type: OTHER

Identifier Source: secondary_id

111276

Identifier Type: OTHER

Identifier Source: secondary_id

2006-004041-42

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

108251

Identifier Type: -

Identifier Source: org_study_id