NCT00381615

Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 147 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 55 Days – 89 Days
• Healthy volunteers: Accepted

Summary

This study was aimed to explore safety and immunogenicity of two formulations of a Meningococcal B Vaccine when administered to healthy infants.

Conditions

• Healthy

Interventions

Type	Name	Description
BIOLOGICAL	rMenB	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.
BIOLOGICAL	rMenB+OMV	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.
BIOLOGICAL	DTaP-Hib-IPV	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.
BIOLOGICAL	PC7	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.
BIOLOGICAL	MenC-CRM	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.
BIOLOGICAL	MenC-Hib	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.
BIOLOGICAL	MMR	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.

Timeline

• Start date: 2006-09-01
• Primary completion: 2007-07-01
• Completion: 2008-08-01
• First posted: 2006-09-28
• Last updated: 2015-10-09
• Results posted: 2015-10-09

Locations

3 sites across 1 country: United Kingdom