NCT00262002 - Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants | Biotech Hunter

Enrollment

601

Participants

Timeline

Start Date

September 30, 2004

Primary Completion Date

July 31, 2005

Study Completion Date

October 31, 2006

Conditions

Prevention of Meningococcal Disease

Interventions

BIOLOGICAL

MenACWY Ad- (MenACWY-CRM, non adjuvanted formulation)

MenACWY-CRM conjugate vaccine formulated without adjuvant was injected IM (intramuscularly) in the anterolateral area of the right thigh.

BIOLOGICAL

MenACWY Ad+ (MenACWY-CRM, adjuvanted formulation)

MenACWY-CRM conjugate vaccine formulated with adjuvant was injected IM in the anterolateral area of the right thigh.

BIOLOGICAL

MenACWY PS (MenACWY-CRM, polysaccharide vaccine)

MenACWY polysaccharide vaccine was injected in the anterolateral area of the right thigh.

BIOLOGICAL

HBV (Hepatitis B vaccine)

Hepatitis B vaccine at 2, 4, 6 months of age administered IM in the anterolateral area of the left thigh.

BIOLOGICAL

Prevnar (pneumococcal polysaccharide serotypes 4, 9V, 14, 18C, 19F, 23F & 6B conjugated to the CRM197)

Prevnar was administered IM in the anterolateral area of the left thigh.

BIOLOGICAL

MMR (Measles, Mumps and Rubella vaccine)

MMR at 12 month of age, administered in the left arm.

BIOLOGICAL

DTaPHibIPV (Diphtheria, Tetanus, acellular Pertussis, H. Influenzae type b, Inactivated Poliovaccine)

DTaPHibIPV at 2, 3, 4 months of age, administered IM in the anterolateral area of the left thigh.

BIOLOGICAL

Menjugate (Men C conjugated vaccine)

Menjugate was injected IM in the anterolateral area of the right thigh.

Trial Locations (3)

Vaccine Evaluation Center, Vancouver

Clinical Trial Research Center, Halifax

Oxford Vaccine Group, Oxford