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

PHASE2CompletedINTERVENTIONAL
Enrollment

147

Participants

Timeline

Start Date

September 30, 2006

Primary Completion Date

July 31, 2007

Study Completion Date

August 31, 2008

Conditions
Healthy
Interventions
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.

Trial Locations (3)

GLI 3NN

Gloucester

NW9 5EQ

London

OX3 7LJ

Oxford

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Novartis Vaccines

INDUSTRY