Safety and immunogenicity of a quadrivalent meningococcal conjugate vaccine (MenACYW-DT): A multicenter, open-label, non-randomized, phase III clinical trial

2014 ◽  
Vol 51 (6) ◽  
pp. 451-456 ◽  
Author(s):  
Sangeeta Yadav ◽  
M. V. Manglani ◽  
D. H. Ashwath Narayan ◽  
S. Sharma ◽  
H. S. Ravish ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Conjugate Vaccine ◽  
Phase Iii ◽  
Open Label ◽  
Phase Iii Clinical Trial ◽  
Quadrivalent Meningococcal Conjugate Vaccine

Measurement of viral interferon sensitivity in patients with chronic hepatitis C. Prospective, randomised, open label phase III clinical trial

2002 ◽  
Vol 36 ◽  
pp. 135-136 ◽  
Author(s):  
Wolfgang Vogel ◽  
Harald Brunner ◽  
Werner Lin ◽  
Rudolf Stauber ◽  
Karin Ptacek-Wegerer ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Chronic Hepatitis ◽  
Hepatitis C ◽  
Chronic Hepatitis C ◽  
Phase Iii ◽  
Open Label ◽  
Phase Iii Clinical Trial ◽  
Open Label Phase

scholarly journals Enhanced antipneumococcal antibody electrochemiluminescence assay: validation and bridging to the WHO reference ELISA

Bioanalysis ◽  
2020 ◽  
Vol 12 (19) ◽  
pp. 1363-1375
Author(s):  
Katrina M Nolan ◽  
Yuhua Zhang ◽  
Joseph M Antonello ◽  
Adrienne H Howlett ◽  
Cyrille J Bonhomme ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Clinical Trials ◽  
Conjugate Vaccine ◽  
Threshold Value ◽  
Phase Iii ◽  
Capsular Polysaccharides ◽  
Acceptance Criteria ◽  
Phase Iii Clinical Trial ◽  
Assay Validation ◽  
Clinical Trial Program

Aim: To re-optimize the pneumococcal (Pn) electrochemiluminescence (ECL) assay and to validate and bridge the enhanced assay to the WHO ELISA, to support the Phase III clinical trial program for V114, a 15-valent Pn conjugate vaccine. Materials & methods: The Pn ECL assay was re-optimized, validated and formally bridged to the WHO ELISA. Results: The enhanced Pn ECL assay met all prespecified validation acceptance criteria and demonstrated concordance with the WHO ELISA. The corresponding threshold value remains at 0.35 μg/ml for all 15 serotypes. Conclusion: The enhanced Pn ECL assay has been validated for the measurement of antibodies to 15 Pn capsular polysaccharides and is concordant with the WHO ELISA, supporting its use in clinical trials.

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