Last updated: 11/04/2018 03:33:56
Study to Evaluate the Response Rate to the Licensed Pneumovax 23™ in Elderly Population.
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
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.
Trial description: 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.
Primary purpose:
Prevention
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Non-randomized
Primary outcomes:
Response rate to 11 vaccine serotypes
Timeframe: One month post vaccination
Secondary outcomes:
Anti-polysaccharide total IgG ELISA for 11 vaccine pneumococcal serotypes
Timeframe: At all time points
Opsonophagocytic activity against 11 vaccine pneumococcal serotypes in a subset of subjects
Timeframe: 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
Timeframe: One month post vaccination
Persistence of the immune response in a subset of subjects.
Timeframe: Until Month 36.
Opsonophagocytic activity response in a subset of subjects.
Timeframe: At Day 30
Occurrence of serious adverse events (SAE).
Timeframe: Up to 1 month after vaccination.
Occurrence of study related SAEs.
Timeframe: Throughout the study period.
Interventions:
Biological/vaccine: Pneumovax 23™
Enrollment:
1198
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Streptococcus pneumoniae Vaccines
Product
SB513026
Collaborators
Not applicable
Study date(s)
October 2003 to February 2005
Type
Interventional
Phase
2
Participation criteria
Sex
Female & Male
Age
65+ years
Accepts healthy volunteers
Yes
- Inclusion criteria
- Subjects who the investigator believes will comply with the requirements of the protocol.
Inclusion and exclusion 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. 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.
Inclusion criteria
Trial location(s)
Study documents
Clinical study report
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2005-25-02
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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