drugset / Trial / NCT01000974
Consistency & Immunogenicity Study of 3 Lots of GSK's Hib Conjugate Vaccine Versus ActHIB & Pentacel in Healthy Infants
RandomizedParallel-groupDouble-blindPrevention
Summary
The purpose of this study is to evaluate safety, to demonstrate lot-to-lot consistency of the vaccine, to address the relevant concomitant vaccine administrations and to provide a comparison between GSK Biologicals' Hib conjugate vaccine and the licensed monovalent Hib vaccine ActHIB as well as the licensed combination product Pentacel in infants at 2, 4, 6 and 15-18 months of age. This study is designed with a primary and a booster phase.
Timeline
- Start
- 2010-06-18
- Primary completion
- 2011-11-18
- Completion
- 2013-07-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | ActHIB | Vaccine | — | Intramuscular |
| Subject | Adacel | Vaccine | — | Intramuscular |
| Comparator | Engerix-B | Vaccine | — | Intramuscular |
| Subject | GSK 208108 | Vaccine | — | Intramuscular |
| Subject | Pediarix | Vaccine | — | Intramuscular |
| Comparator | Pentacel | Vaccine | — | Intramuscular |
| Background | Prevnar 13 | Vaccine | — | Intramuscular |
| Background | Rotarix | Vaccine | — | Oral |