Study to Evaluate the Response Rate to the Licensed Pneumovax 23™ in Elderly Population.
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ClinicalTrials.gov Identifier: NCT00307008 |
Recruitment Status :
Completed
First Posted : March 27, 2006
Last Update Posted : April 15, 2013
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Streptococcus Pneumoniae Vaccines | Biological: Pneumovax 23™ | Phase 2 |
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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 1198 participants |
Allocation: | Non-Randomized |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
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. |
Study Start Date : | October 2003 |
Actual Primary Completion Date : | February 2005 |
Actual Study Completion Date : | February 2005 |

Arm | Intervention/treatment |
---|---|
Experimental: Group A |
Biological: Pneumovax 23™
Single dose intramuscular injection |
- Response rate to 11 vaccine serotypes [ Time Frame: One month post vaccination ]
- Anti-polysaccharide total IgG ELISA for 11 vaccine pneumococcal serotypes [ Time Frame: At all time points ]
- Opsonophagocytic activity against 11 vaccine pneumococcal serotypes in a subset of subjects [ Time Frame: At Day 0 and Day 30. ]
- The rank of subjects from "poorest responder" to "best responder" based on the number of serotypes each subject responds to [ Time Frame: One month post vaccination ]
- Persistence of the immune response in a subset of subjects. [ Time Frame: Until Month 36. ]
- Opsonophagocytic activity response in a subset of subjects. [ Time Frame: At Day 30 ]
- Occurrence of serious adverse events (SAE). [ Time Frame: Up to 1 month after vaccination. ]
- Occurrence of study related SAEs. [ Time Frame: Throughout the study period. ]

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00307008
Sweden | |
GSK Investigational Site | |
Eskilstuna, Sweden, SE-631 88 | |
GSK Investigational Site | |
Jönköping, Sweden, SE-551 85 | |
GSK Investigational Site | |
Skövde, Sweden, SE-541 85 | |
GSK Investigational Site | |
Uppsala, Sweden, SE-751 85 | |
GSK Investigational Site | |
Västerås, Sweden, SE 721 89 |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT00307008 |
Other Study ID Numbers: |
513026/004 100421 100436 |
First Posted: | March 27, 2006 Key Record Dates |
Last Update Posted: | April 15, 2013 |
Last Verified: | September 2011 |
Prophylaxis Invasive pneumococcal diseases and pneumonia |
Pneumonia Pneumonia, Pneumococcal Respiratory Tract Infections Infections Lung Diseases Respiratory Tract Diseases Pneumococcal Infections Streptococcal Infections |
Gram-Positive Bacterial Infections Bacterial Infections Bacterial Infections and Mycoses Pneumonia, Bacterial Heptavalent Pneumococcal Conjugate Vaccine Immunologic Factors Physiological Effects of Drugs |