NCT00667602

Safety and Immunogenicity Evaluation After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Infants and Toddlers

A Phase 3, Open-Label, Randomized, Multi-Center Study to Evaluate the Safety and Immunogenicity After One or Two Doses of Novartis Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Toddlers

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 662 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 6 Months – 8 Months
• Healthy volunteers: Accepted

Summary

The primary immunogenicity objective is to assess and compare the immunogenicity of one dose of MenACWY to one dose of Menjugate given to healthy toddlers at 12 months of age as measured by the percentage of subjects with serum bactericidal titers directed against N. meningitidis serogroup C ≥ 1:8 obtained in the serum bactericidal assay using human complement (hSBA).

Conditions

• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	MenACWY-CRM197 (two doses)	Two 0.5mL doses of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.
BIOLOGICAL	MenC	One 0.5mL dose of MenC vaccine was administered by intramuscular injection.
BIOLOGICAL	PCV7	One 0.5mL dose of Pneumococcal 7-valent Conjugate Vaccine (PCV7) was administered by intramuscular injection.
BIOLOGICAL	DTPa-IPV-HepB-Hib	One 0.5mL dose of Combined Diphtheria-Tetanus-acellular Pertussis, Hepatitis B, Inactivated Poliovirus and Haemophilus influenzae type b (DTPa-IPV-HepB-Hib) vaccine was administered by intramuscular injection.
BIOLOGICAL	MenACWY-CRM197 (one dose)	One 0.5mL dose of MenACWY conjugate vaccine (MenACWY-CRM197) was administered by intramuscular injection.

Timeline

• Start date: 2008-03-01
• Primary completion: 2009-07-01
• Completion: 2010-10-01
• First posted: 2008-04-28
• Last updated: 2013-11-07
• Results posted: 2013-11-07

Locations

28 sites across 1 country: Germany