Placebo Controlled Study to Generate Data Characterising Clinical Events, Physiological Responses and Immune Responses

Phase 4 Completed 240 enrolled University Hospital, Ghent GlaxoSmithKline · collab Innovative Medicines Initiative · collab Max Planck Institute for Infection Biology · collab Novartis Vaccines · collab University of Surrey · collab VisMederi srl · collab deCODE genetics · collab

RandomizedParallel-groupTriple-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, 228 will be administered a dose of Fluad on Day 0, 12 will receive a placebo on Day 0.

Timeline

Start: 2014-10-02
Primary completion: 2016-08-01
Completion: 2016-08-01

Publications

Muturi-Kioi V, Lewis D, Launay O, Leroux-Roels G, Anemona A, Loulergue P, Bodinham CL, Aerssens A, Groth N, Saul A, Podda A. Neutropenia as an Adverse Event following Vaccination: Results from Randomized Clinical Trials in Healthy Adults and Systematic Review. PLoS One. 2016 Aug 4;11(8):e0157385. doi: 10.1371/journal.pone.0157385. eCollection 2016.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Fluad	Vaccine	0.5 ml	Intramuscular

Indications

No indication recorded.