Industrial projects

  1. Etudes industrielles à venir:

Etudes Porteur de projets Titres

GARDASIL

V-503-049

 MSD

A Phase III International, Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial to Study the Efficacy, Immunogenicity, and Safety of the 9vHPV Vaccine, a Multivalent Human Papillomavirus (HPV) L1 Virus-like Particle (VLP) Vaccine, in the prevention of HPV oral persistent infection (PI) with HPV Types 16/18/31/33/45/52/58, in adult males, 20 to 45 years old. 

IMOVE-COVID EPICONCEPT Multidisciplinary European network for research, preventio, and control of the COVID 19 Pandemic

RSV MAT-009

GSK  A Phase III, randomized, double-blind, placebocontrolled multi-country study to demonstrate efficacy of a single dose of RSV Maternal (RSVPreF3) unadjuvanted vaccine (GSK3888550A), administered IM to pregnant women 18 to 49 years of age, for prevention of RSV LRTI in their infants up to 6 months of age

 

  1. Etudes industrielles en cours de réalisation:

 

Etudes Porteur de projets Centres Titres
QHD00011  SANOFI 3 centers participate including 2 network centers  : Cochin, URCI de Lyon (Coordination : J.F Nicolas) et 1 privated center A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the
Pharmacokinetics, Safety, and Antiviral Activity of JNJ-63623872 in Combination With Oseltamivir in Adolescent, Adult, and Elderly Hospitalized Patients With Influenza A Infection
V114-018   MSD  3 network centers  : Cochin, Clermont-Ferrand et St-Louis A Phase III, Multicenter, Randomized, Double-blind, Active Comparator controlled Study to Evaluate the Safety, Tolerability, and Immunogenicity of V114 Followed by Administration of PNEUMOVAX™23 Eight Weeks Later in Adults Infected with HIV (PNEU–WAY). 
ETUDE B5091007 (CLOVER)  Pfizer   4 Network centers  : Cochin, Dijon, St-Etienne et Tours Phase III, randomized, placebo-controlled, blinded observer study to assess the efficacy, safety and tolerability of a Clostridium difficile vaccine in adults aged 50 years and older.
VAC52150EBL4001/JANSSEN (étude de suivi des sujets inclus dans Ebocvac2) Projet IMI  Inserm/Janssen   6 Network centers  : Cochin, Rennes, Saint-Etienne, Strasbourg, Tours et URCI Lyon.  Prospective international study on the clinical tolerance od subjects exposed to candidate vaccines against the Ebolz virus ad26.ZEBOV and/or MVA-BN-Filo
NTHI MCAT-009 GSK

3 network centers  : Cochin, Montpellier et Rennes. 

Phase IIA study, open to evaluate the immunogenicity ans tolerance of the sequential  use of the experimental GSK vaccine GSK 3277511A, when this vaccine is administered to healty subjects, smokers and former smokers, aged 50 to 80 years , after have received the Shingrix vaccine
RSV MAT 004 GSK  3 network centers participate : Cochin, Saint Etienne et Clermont Ferrand  A Phase I/II, randomized, observer-blind, controlled multi-country study to assess the safety, reactogenicity and immunogenicity of a single intramuscular dose of GSK Biologically’ investigational RSV Maternal unadjuvanted vaccine (GSK3003891A), in healthy pregnant women aged 18 to 40 years and infants born to vaccinated mothers. 
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