Safety and Efficacy Study of Investigational Pneumococcal Vaccine in Elderly Population

NCT ID: NCT00307528

Last Updated: 2019-10-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 146 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-20
• Study Completion Date: 2005-03-30

Brief Summary

As the licensed Pneumovax 23™ vaccine is not always satisfactory in elderly subjects, the safety and the immune response of the new investigational pneumococcal protein vaccine is evaluated in healthy elderly population.

Detailed Description

Since influenza vaccination is recommended in the age range of the study population, Fluarix™ (GlaxoSmithKline Biologicals) vaccine will be offered free of charge during the study period (for 3 consecutive years starting from September 2004), to be used by Investigators according to national vaccination schedule/practice.

The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

Conditions

Prophylaxis Invasive Pneumococcal Diseases and Pneumonia

Study Design

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

Study Groups

Group A

Group Type: ACTIVE_COMPARATOR

Pneumovax 23™

Intervention Type: BIOLOGICAL

Single dose intramuscular injection.

Group B

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK513026

Intervention Type: BIOLOGICAL

Two-dose intramuscular injection. Five different formulations, each administered to one Group

Group C

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK513026

Intervention Type: BIOLOGICAL

Two-dose intramuscular injection. Five different formulations, each administered to one Group

Group D

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK513026

Intervention Type: BIOLOGICAL

Two-dose intramuscular injection. Five different formulations, each administered to one Group

Group E

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK513026

Intervention Type: BIOLOGICAL

Two-dose intramuscular injection. Five different formulations, each administered to one Group

Group F

Group Type: EXPERIMENTAL

Pneumococcal vaccine GSK513026

Intervention Type: BIOLOGICAL

Two-dose intramuscular injection. Five different formulations, each administered to one Group

Interventions

Pneumococcal vaccine GSK513026

Two-dose intramuscular injection. Five different formulations, each administered to one Group

Intervention Type: BIOLOGICAL

Pneumovax 23™

Single dose intramuscular injection.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• Subjects who the investigator believes will comply with the requirements of the protocol
• A male or female ≥ 65 years at the time of the first vaccination.
• Written informed consent obtained from the subject.
• Free of obvious health problems as established by medical history and clinical examination before entering into the study.

Exclusion Criteria

• Use of any investigational or non-registered product (drug or vaccine) other than the study vaccine(s) within 30 days preceding the first dose of study vaccine, or planned use during the study period or participation to another pharmaceutical/vaccine study.
• Chronic administration (defined as more than 14 days) of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.
• Use of any anticoagulants.
• Planned administration/ administration of a vaccine not foreseen by the study protocol within 2 weeks of the first dose of vaccines.
• Previous vaccination against Streptococcus pneumoniae.
• Bacterial pneumonia within 3 years prior to 1st vaccination.
• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.
• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
• Current serious neurologic or mental disorders.
• Currently smoking > 25 cigarettes per day.
• Inflammatory processes such as known chronic active infections
• All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.
• History of administration of an experimental vaccine containing MPL or QS21.
• Acute disease at the time of enrolment.
• Acute or chronic, clinically significant pulmonary, cardiovascular, hepatic or renal functional abnormality, as determined by physical examination or laboratory screening tests, at the discretion of the investigator.
• History of chronic alcohol consumption and/or intravenous drug abuse.

• Minimum Eligible Age: 65 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

Ghent, , Belgium

Countries

Belgium

References

Leroux-Roels I, Devaster JM, Leroux-Roels G, Verlant V, Henckaerts I, Moris P, Hermand P, Van Belle P, Poolman JT, Vandepapeliere P, Horsmans Y. Adjuvant system AS02V enhances humoral and cellular immune responses to pneumococcal protein PhtD vaccine in healthy young and older adults: randomised, controlled trials. Vaccine. 2015 Jan 15;33(4):577-84. doi: 10.1016/j.vaccine.2013.10.052. Epub 2013 Oct 29.

Reference Type: DERIVED

PMID: 24176494 (View on PubMed)

Other Identifiers

100463

Identifier Type: OTHER

Identifier Source: secondary_id

100464

Identifier Type: OTHER

Identifier Source: secondary_id

100409

Identifier Type: -

Identifier Source: org_study_id