A Phase III Randomized, Double-Blind, Active-Comparator Controlled Clinical Trial to Study the Safety, Tolerability, and Immunogenicity of V419 in Healthy Infants When Given at 2, 3, 4, and 12 Months 1. To evaluate the immunogenicity of PR5I when given at 2, 3, 4, and 12 months. 2. To compare the immunogenicity response elicited by PR5I to that of INFANRIX hexa when given at 2, 3, 4, and 12 m...

• Country None
• organs None
• Specialty None

A randomised, controlled, double blind study of the immunogenicity and safety of PEDIACEL®, a combined diphtheria, tetanus, five component acellular pertussis, inactivated poliomyelitis and Haemophilus influenzae type b conjugate vaccine (adsorbed) compared to Infanrix™–IPV+Hib when both vaccines are given to infants using a three dose immunisation schedule (“Nordic schedule” 3-5-12 months) To assess the immunogenicity post-dose 3 of PEDIACEL® (Group A) and Infanrix™–IPV+Hib (Group B) when administered to infants at 3, 5 and 12 months of age.

• Country None
• organs None
• Specialty None

Sanofi-Aventis VITAL : Essai de phase 3 randomisé, en double aveugle, comparant l’efficacité d’un traitement par docétaxel associé ou non à l’aflibercept chez des patients ayant un cancer du poumon. [Informations issues du site clinicaltrials.gov et traduites par l'INCa] [essai clos aux inclusions] A multinational, randomized, double-blind study comparing aflibercept versus placebo in patients treated with second-line docetaxel after failure of one platinum based therapy for locally advanced or ...

• Country France
• organs Poumon, type non à petites cellules
• Specialty Chimiothérapie, Thérapies Ciblées

A Multicenter, Open-Label, Randomized, Phase III Trial Comparing Immediate Adjuvant Hormonal Therapy (ELIGARD®- leuprolide acetate) in Combination with TAXOTERE® (docetaxel) Administered Every Three Weeks Versus Hormonal Therapy Alone Versus Deferred Therapy Followed by the Same Therapeutic Options in Patients with Prostate Cancer at High Risk of Relapse After Radical Prostatectomy The primary objective of the study is to compare progression-free survival (PSA progression after systemic treatment, radiologically or histologically documented progression after systemic treatment o...

• Country None
• organs None
• Specialty None

An open-label, single-arm, phase IV study assessing the immunogenicity and safety of ZOSTAVAX at minimum release specification approaching expiry potency in subjects ≥50 years old To demonstrate whether or not ZOSTAVAX® at minimum release specification and approaching expiry potency elicits an acceptable VZV antibody fold rise (gpELISA) from pre-vaccination to 4 weeks post-vacc...

• Country None
• organs None
• Specialty None

Placebo controlled double blind dose ranging study of the efficacy and safety of SSR149744C 50, 100, 200, or 300 mg OD, with amiodarone as calibrator for the maintenance of sinus rhythm in patients with recent atrial fibrillation/flutter To evaluate the efficacy of SSR149744C and select a dose to be further investigated in the maintenance of sinus rhythm after electrical, pharmacological or spontaneous conversion of AF/AFL.

• Country None
• organs None
• Specialty None

Sanofi-Aventis EFC10547 : Essai de phase 3, randomisé, en double aveugle évaluant l’efficacité d’une chimiothérapie associant l’aflibercept à la gemcitabine chez des patients ayant un cancer du pancréas métastatique. [Informations issues du site clinicaltrials.gov et traduites par l'INCa] [essai clos aux inclusions] L’objectif de cet essai est d’évaluer l’aflibercept en association avec la gemcitabine dans le traitement du cancer du pancréas métastatique. Les patients seront répartis de façon aléatoire entre 2 g...

• Country France
• organs Pancréas
• Specialty Chimiothérapie

Study of Aflibercept as Maintenance Following Induction of Aflibercept in Combination with XELOX, as First-Line Treatment for Metastatic Colorectal Cancer Patient Studio con aflibercept come terapia di mantenimento dopo induzione con aflibercept in combinazione con XELOX, come prima linea di trattamento in pazienti affetti da tumore del colon-retto metastatico Study Part 1: To determine the recommended dose for the aflibercept, oxaliplatin and capecitabine (XELOX) combination to be used in the Part 2 of the study Study Part 2: To assess the percentage of ...

• Country None
• organs None
• Specialty None

A multicenter, randomized double-blind placebo controlled Phase III study of the efficacy of xaliproden in preventing the neurotoxicity of oxaliplatin in first-line treatment of patients with metastatic colorectal cancer treated with oxaliplatin/5-FU/LV Neuroprotection: Reduction in the risk of occurrence of Grade 3-4 cumulative peripheral sensory neuropathy (PSN) relative to cumulative dose of oxaliplatin.

• Country None
• organs None
• Specialty None

Population pharmacokinetics study with Amaryl® (Glimepiride) in pediatric and adult population with type 2 diabetes To investigate the pharmacokinetics of Amaryl® in pediatric patients (8 to 16 years of age) with type 2 diabetes in comparison with adults patients (17 years or older of age) with type 2 diabetes unde...

• Country None
• organs None
• Specialty None