NCT00262002

Study of the Safety and Immune Response of a Meningococcal Vaccine Administered to Healthy Infants

A Phase II, Randomized, Open Label, Controlled, Multicenter Study to Evaluate the Safety, Immunogenicity and Induction of Immunological Memory After Two or Three Doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants at 2, 3, 4 or 2, 4, 6 Months of Age

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 601 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 2 Months – 6 Months
• Healthy volunteers: Accepted

Summary

The purpose of this study is to evaluate the safety, immunogenicity and induction of immune memory after two or three doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine administered to healthy infants.

Conditions

• Prevention of Meningococcal Disease

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2004-09-01
• Primary completion: 2005-07-01
• Completion: 2006-10-01
• First posted: 2005-12-06
• Last updated: 2014-06-18
• Results posted: 2014-06-18

Locations

3 sites across 2 countries: Canada, United Kingdom