Study to Evaluate the Response Rate to the Licensed Pneumovax 23™ in Elderly Population.

Streptococcus Pneumoniae Vaccines Clinical Trial

Official title:

An Open, Phase II Study to Evaluate the Response Rate to the Licensed Single-Dose Polysaccharide Pneumococcal Vaccine Pneumovax 23™ (MSD Aventis Pasteur) in Elderly Population.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00307008
• Other study ID #: 513026/004
• Secondary ID: 100421100436
• Status: Completed
• Phase: Phase 2
• First received: March 24, 2006
• Last updated: April 11, 2013
• Start date: October 2003
• Est. completion date: February 2005

Study information

• Verified date: September 2011
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Swedish National Council on Medical Ethics
• Study type: Interventional

Clinical Trial Summary

Streptococcus pneumoniae are bacteria which normally live in the upper respiratory tract of humans. However, these bacteria can also cause severe infectious diseases such as pneumonia, septicemia and meningitis. Elderly subjects are especially vulnerable to these infections, and the diseases can result in death. The currently available licensed Streptococcus pneumoniae vaccine is recommended for prevention of pneumococcal diseases in individuals over the age of 65. However, the antibody level elicited by this vaccine, is not always satisfactory in elderly people. To overcome the problem, GlaxoSmithKline Biologicals is currently developing candidate vaccines that are hoped to work better than the currently available vaccines. As a first step in this development, the present study is being conducted in order to evaluate the immune response to the currently marketed vaccine.

Description:

Since influenza vaccination is recommended in the age range of the study population, Fluarix™ (GlaxoSmithKline Biologicals) vaccine will be offered free of charge for the study period (3 consecutive years), 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1198
• Est. completion date: February 2005
• Est. primary completion date: February 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 65 Years and older

Eligibility

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.

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.

• Previous vaccination against Streptococcus pneumoniae.

• History of administration of an experimental vaccine containing MPL or QS21.

• History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.

• Planned administration of a vaccine not foreseen by the study protocol within 2 weeks before and after first dose of vaccines, excluding influenza vaccine which can be administered at any time, including co-administration with Pneumovax23™.

• Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to the first vaccine dose.

• Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection.

• Current serious neurologic or mental disorders.

• Inflammatory processes such as known chronic active infections (e.g.Hep B, C).

• All malignancies (excluding non-melanic skin cancer) and lymphoproliferative disorders diagnosed or treated actively during the past 5 years.

• Acute disease at the time of enrolment.

• Chronic disease that might preclude participation to the whole study.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Pneumonia
• Streptococcus Pneumoniae Vaccines

Intervention

Biological:
• Pneumovax 23™
Single dose intramuscular injection

Locations

Country	Name	City	State
Sweden	GSK Investigational Site	Eskilstuna
Sweden	GSK Investigational Site	Jönköping
Sweden	GSK Investigational Site	Skövde
Sweden	GSK Investigational Site	Uppsala
Sweden	GSK Investigational Site	Västerås

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response rate to 11 vaccine serotypes		One month post vaccination	No
Secondary	Anti-polysaccharide total IgG ELISA for 11 vaccine pneumococcal serotypes		At all time points	No
Secondary	Opsonophagocytic activity against 11 vaccine pneumococcal serotypes in a subset of subjects		At Day 0 and Day 30.	No
Secondary	The rank of subjects from "poorest responder" to "best responder" based on the number of serotypes each subject responds to		One month post vaccination	No
Secondary	Persistence of the immune response in a subset of subjects.		Until Month 36.	No
Secondary	Opsonophagocytic activity response in a subset of subjects.		At Day 30	No
Secondary	Occurrence of serious adverse events (SAE).		Up to 1 month after vaccination.	Yes
Secondary	Occurrence of study related SAEs.		Throughout the study period.	Yes