Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers

Phase 3 Completed 662 enrolled Novartis Vaccines

RandomizedParallel-groupOpen-labelPrevention

Summary

The primary immunogenicity objective is to assess and compare the immunogenicity of one dose of MenACWY to one dose of Menjugate given to healthy toddlers at 12 months of age as measured by the percentage of subjects with serum bactericidal titers directed against N. meningitidis serogroup C ≥ 1:8 obtained in the serum bactericidal assay using human complement (hSBA).

Timeline

Start: 2008-03
Primary completion: 2009-07
Completion: 2010-10

Publications

Giuliani MM, Biolchi A, Keshavan P, Moriondo M, Tomei S, Santini L, Mori E, Brozzi A, Bodini M, Nieddu F, Ricci S, Mzolo T, Costantini M, Azzari C, Pellegrini M. Bactericidal antibodies against hypervirulent Neisseria meningitidis C field strains following MenC-CRM or MenACWY-CRM priming and MenACWY-CRM booster in children. Hum Vaccin Immunother. 2021 May 4;17(5):1442-1449. doi: 10.1080/21645515.2020.1833578. Epub 2020 Dec 16.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	MenACWY-CRM197	Vaccine	0.5 ml	Intramuscular
Comparator	MenC	Vaccine	0.5 ml	Intramuscular
Background	DTPa-IPV-HepB-Hib	Vaccine	0.5 ml	Intramuscular
Background	Prevnar 13	Vaccine	0.5 ml	Intramuscular

Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers

Summary

Timeline

Publications

Drugs

Indications