drugset / Trial / NCT02555540
Placebo Controlled Study to Generate Data Characterising Safety Parameters and Immune Responses
Phase 4
Completed
240 enrolled
University Hospital, Ghent
GlaxoSmithKline · collabInnovative Medicines Initiative · collabMax Planck Institute for Infection Biology · collabNovartis Vaccines · collabSanofi Pasteur, a Sanofi Company · collabUniversity of Surrey · collabdeCODE genetics · collab
RandomizedParallel-groupQuadruple-blindBasic science
Summary
The purpose of this protocol is to generate a set of data that will be analysed by integrated systems biology approach, for validation in subsequent clinical trials or in animal models. 240 healthy participants (18-45y) will be enrolled, 200 will be administered a dose of Boostrix on Day 0, 20 will receive a placebo on Day 0.
Timeline
- Start
- 2015-08-24
- Primary completion
- 2015-12-15
- Completion
- 2016-12-15
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Boostrix | Vaccine | — | Intramuscular |
Indications
No indication recorded.