drugset / Trial / NCT00133549
9-valent CRM 197 Pneumococcal
RandomizedCrossoverDouble-blindPrevention
Summary
The purpose of this study is to evaluate the safety and immune response of a conjugated pneumococcal vaccine compared to a licensed 23-valent polysaccharide pneumococcal vaccine in elderly adults. Study participants will include 180 adults, 65 years of age or greater. Participants will be randomly assigned to 1 of 3 possible groups. Subjects will maintain a study diary to record side effects and oral temperatures for 7 days following each vaccination. Blood samples will be collected before and 1 month following each dose of vaccine or placebo. Participants will be involved in study related procedures for up to 268 days.
Timeline
- Start
- 2000-11
- Primary completion
- 2002-12
- Completion
- 2002-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | PNCRM9 | Vaccine | 0.5 ml | Intramuscular |
| Subject | Pneumovax 23 | Vaccine | 0.5 ml | Intramuscular |