WHO ICTRP trial

A study to investigate the safety and immunogenicity of different formulations…

EUCTR2017-003692-61-DE · EU Clinical Trials Register · Not Recruiting

Key facts

Trial ID EUCTR2017-003692-61-DE
Public title A study to investigate the safety and immunogenicity of different formulations of GSK Biologicals’ Meningococcal ACWY conjugate vaccine (GSK3536820A and Menveo) administered to healthy adults 18 to 40 years of age
Scientific title A phase 2b, randomized, controlled, observer-blind, multi-center, non-inferiority immunogenicity and safety study of two formulations of GSK Biologicals’ Meningococcal ACWY conjugate vaccine (GSK3536820A and Menveo) administered to healthy adults 18 to 40 years of age. - MENACWY CONJ-032_V59_71
Primary sponsor GlaxoSmithKline Biologicals
Registry EU Clinical Trials Register
Recruitment status Not Recruiting
Study type Interventional clinical trial of medicinal product
Phase Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no
Countries Estonia;Canada;Belgium;Australia;Germany;Italy
Conditions Prophylaxis against bacterial meningitis MedDRA version: 20.0 Level: PT Classification code 10027249 Term: Meningitis meningococcal System Organ Class: 10021881 - Infections and infestations ;Therapeutic area: Diseases [C] - Bacterial…
Interventions Trade Name: Menveo Product Code: Meningococcal group A, C, W135 and Y conjugate vac Pharmaceutical Form: Powder and solution for solution for injection INN or Proposed INN: - Current Sponsor code: MenA-CRM197 conjugate Other descriptive…
Registration date Apr 27, 2018
Target size 972
Secondary IDs 205343
Registry page clinicaltrialsregister.eu

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