CompletedPhase 2

Safety and Efficacy Study of Investigational Pneumococcal Vaccine in Elderly Population

Belgium146 participantsStarted 2004-01-20

Plain-language 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.

Who can participate

Age range

65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 (e…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Occurrence, intensity and relationship of any solicited local and general signs and symptoms.

Timeframe: During a 7-day follow up period after each vaccine dose.

Occurrence, intensity and relationship to vaccination of unsolicited local and general signs and symptoms.

Timeframe: During a 30-day follow up period after each vaccine dose.

Occurrence of all serious adverse events (SAE).

Timeframe: During the entire study period.

Anti- PhtD antibody concentration

Timeframe: One month after the first injection

Anti-PhtD antibody concentration.

Timeframe: One month after 2 injections

Trial details

NCT IDNCT00307528

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2005-03-30

View on ClinicalTrials.gov More Prophylaxis Invasive Pneumococcal Diseases and Pneumonia trials