B Cell Response to a Primary and a Booster Course of the Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants

PHASE2CompletedINTERVENTIONAL
Enrollment

216

Participants

Timeline

Start Date

July 31, 2007

Primary Completion Date

May 31, 2009

Study Completion Date

June 30, 2009

Conditions
Meningococcal Disease
Interventions
BIOLOGICAL

MenACWY-CRM

One dose (0.5 mL) of MenACWY conjugate vaccine supplied as an extemporaneous mixing just before injection of the lyophilized component (MenA) reconstituted with the liquid component (MenCWY) was administered at 2-, 4-, and 12-months as IM injections in the anterolateral area of the right thigh.

BIOLOGICAL

DTaP-Hib-IPV

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.

BIOLOGICAL

PCV

IM injections of 3 doses of 0.5 mL each of PCV supplied in pre-filled syringe were administered at 2-, 4-, and 12-months (Groups 2 and 3) or 13-months (Group 1) in the anterolateral area of the left 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 in the anterolateral area of the left thigh.

BIOLOGICAL

Hib

IM injection of one dose 0.5 mL of Hib supplied in pre-filled syringe was administered at 13 months in the anterolateral area of the right thigh.

Trial Locations (1)

OX3 7LJ

Oxford Vaccine Group, Centre for Clinical Vaccinology and Tropical Medicine, Headington

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

Novartis

INDUSTRY

lead

Novartis Vaccines

INDUSTRY