drugset / Trial / NCT00355121
Study of Menactra® in Children Aged 4 to 6 Years When Administered Concomitantly With a Fifth Dose of DAPTACEL®
RandomizedParallel-groupQuadruple-blindPrevention
Summary
The purpose of this study is to evaluate the immunogenicity and safety of the concomitant administration of Menactra® vaccine and DAPTACEL® vaccine. The main objectives are: Immunogenicity: To evaluate the antibody responses to both vaccines when Menactra vaccine is given concomitantly with DAPTACEL® compared to when either vaccine is given alone. Safety: To evaluate the rate of local and systemic reactions when DAPTACEL® and Menactra vaccines are administered concomitantly compared to when each vaccine is given alone.
Timeline
- Start
- 2006-10
- Primary completion
- 2009-06
- Completion
- 2009-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adacel | Vaccine | 0.5 ml | Intramuscular |
| Subject | IPOL | Unknown | 0.5 ml | Intramuscular |
| Subject | Menactra | Vaccine | 0.5 ml | Intramuscular |