NCT00310817

Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.

A Phase II, Randomized, Observer Blind, Multi-Center, Active Controlled Study to Evaluate the Safety and Immunogenicity of Novartis Meningococcal ACWY Conjugate Vaccine in Healthy Children Aged 12-59 Months.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 623 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 12 Months – 59 Months
• Healthy volunteers: Accepted

Summary

To compare the functional immune response 28 days after administration of one dose of Men ACWY-CRM conjugate vaccine without adjuvant (MenACWY-CRM(Ad-)) with that of a Men ACWY polysaccharide (PS) vaccine

Conditions

• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	MenACWY-CRM conjugate vaccine, adjuvanted
BIOLOGICAL	MenACWY polysaccharide vaccine
BIOLOGICAL	MenACWY-CRM conjugate vaccine, unadjuvanted

Timeline

• Start date: 2005-03-01
• Primary completion: 2006-05-01
• Completion: 2006-05-01
• First posted: 2006-04-05
• Last updated: 2015-11-06
• Results posted: 2015-11-06

Locations

2 sites across 2 countries: Finland, Poland