A phase I, double-blind, randomized study to evaluate the safety and immunogenicity of a new Meningococcal A Conjugate vaccine versus a Meningococcal Polysaccharide A+C reference vaccine and a Tetanus Toxoid control vaccine, given as single intramuscular injections in healthy adults from 18 to 35 years of age (India)

Authors
Category Primary study
Registry of TrialsISRCTN registry
Year 2005
INTERVENTION: Single intramuscular injection of one of the following: 1. Study vaccine group: Serum Institute of India Limited (SIIL) PsA‐TT (Meningococcal A Polysaccharide conjugated to Tetanus Toxoid) 2. Reference vaccine group: Sanofi Pasteur Meningococcal Polysaccharide Vaccine A+C 3. Control vaccine group: Serum Institute of India Limited (SIIL) Tetanus Toxoid (Adsorbed) IP CONDITION: Meningococcal disease ; Infections and Infestations ; Meningococcal disease PRIMARY OUTCOME: Incidence of adverse events including solicited adverse events and laboratory abnormalities over 4 weeks post‐vaccination SECONDARY OUTCOME: 1. Descriptive assessment of the immune response 4 weeks post‐vaccination in terms of serum bactericidal activity using baby rabbit complement (SBA/BRC) and anti‐PsA IgG response; 2. Descriptive assessment of the persistence of an immune response 24 and 48 weeks post‐vaccination in terms of SBA/BRC and anti‐PsA IgG response INCLUSION CRITERIA: Healthy adults between 18 and 35 years of age
Epistemonikos ID: c1f15d40ce23f364fa44de20b2db4351a8be3218
First added on: Aug 21, 2024