NCT00433914

Safety, Tolerability and Immunogenicity of Two Different Formulations of Meningococcal B Recombinant Vaccine, When Administered to Healthy Infants

A Phase 2, Single Blind, Single Center, Randomized Study of the Safety, Tolerability and Immunogenicity of Novartis Meningococcal B Recombinant Vaccine +/- OMV, When Administered to Healthy Infants 6-8 Months Old

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 6 Months – 8 Months
• Healthy volunteers: Accepted

Summary

To explore safety, Tolerability and immunogenicity of two formulations of a Meningococcal B Recombinant Vaccine when administered to healthy infants.

Conditions

• Meningococcal Disease

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.

Timeline

• Start date: 2007-02-01
• Primary completion: 2007-12-01
• Completion: 2008-07-01
• First posted: 2007-02-12
• Last updated: 2015-03-06
• Results posted: 2015-03-06

Locations

1 site across 1 country: United Kingdom