At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase 2, Open Label, Multi-Center, Controlled, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine±OMV, When Administered to Healthy Infants at 2, 4, 6 and/or 12 Months of Age
In Brief
A Phase 2 clinical trial evaluating rMenB, rMenB+OMV, and 5 other interventions for Healthy. Completed, enrolled 147 participants across 3 sites.
Detailed Summary
This study was aimed to explore safety and immunogenicity of two formulations of a Meningococcal B Vaccine when administered to healthy infants.
Study Details
Timeline
Interventions
One dose (0.5 mL) of rMenB vaccine without OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.
One dose (0.5 mL) of rMenB vaccine with OMV-NZ supplied as a full liquid formulation in a prefilled syringe was administered into the anterolateral area of the right thigh.
Intramuscular (IM) injections of 3 doses of 0.5 mL each of DTaP-Hib-IPV supplied in prefilled vial were administered at 2, 3 and 4 months in the anterolateral area of the left thigh (when given concomitantly with rMenB±OMV-NZ) or the right thigh.
IM injections of 3 doses of 0.5 mL each of PC7 supplied in prefilled syringe were administered at 2, 4 and 13 months of age in the anterolateral area of the left thigh (when given concomitantly with rMenB±OMV-NZ) or the right thigh.
MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized Men C component to be re-suspended with the saline solvent (aluminum hydroxide suspension) supplied. IM injection of 2 doses each of 0.5 mL were administered into the anterolateral area of the left thigh.
MenC-Hib was obtained by extemporaneous mixing of powder and solvent just before injection. One dose (0.5 mL) of MenC-Hib was administered at 12 months of age as an IM injection into the anterolateral area of the thigh.
IM injection of one dose of 0.5 mL of MMR obtained by extemporaneous mixing just before injection of powder and the solvent for solution was administered at 13 months of age in the anterolateral area of the left thigh.