drugset / Trial / NCT00133549

9-valent CRM 197 Pneumococcal

NCT00133549

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

EvaluationDrugModalityDoseRoute
Subject PNCRM9 Vaccine 0.5 ml Intramuscular
Subject Pneumovax 23 Vaccine 0.5 ml Intramuscular