NCT00310856

Immunogenicity and Safety of MenACWY in Infants (6 & 12 Months)

A Phase 2, Partially Randomized, Open Label, Multicenter Study to Evaluate the Safety and Immunogenicity After One or Two Doses of Novartis (Formerly Chiron) Meningococcal ACWY Conjugate Vaccine Administered to Healthy Infants and Young Children

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 175 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 6 Months – 12 Months
• Healthy volunteers: Accepted

Summary

To assess the immunogenicity of Novartis (formerly Chiron) Meningococcal ACWY conjugate vaccine (MenACWY) when administered as a two-dose schedule at 6 and 12 months of age.

Conditions

• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	MenACWY-CRM	Subjects received the full dose (0.5 mL) of MenACWY-CRM, obtained by extemporaneous mixing of lyophilized MenA powder component and the MenCWY suspension, administered by IM injection into the anterolateral area of the right thigh.
BIOLOGICAL	MenC-CRM	One dose (0.5 mL) of MenC-CRM was obtained by extemporaneous mixing just before injection of the lyophilized MenC component and a saline solvent, administered by IM injection into the arm region.
BIOLOGICAL	DTaP-Hib-IPV
BIOLOGICAL	PC7	One dose (0.5 mL) of PC7, supplied in pre-filled syringe, administered by IM injection into the anterolateral area of the left thigh.
BIOLOGICAL	MMR
BIOLOGICAL	Varicella

Timeline

• Start date: 2005-06-01
• Primary completion: 2006-11-01
• Completion: 2006-11-01
• First posted: 2006-04-05
• Last updated: 2018-10-09
• Results posted: 2013-11-01

Locations

3 sites across 1 country: Canada