NCT01367158

Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY Combination Vaccine in Adolescents Who Previously Received the Same Study Vaccines

Phase 2, Observer-Blind, Controlled, Randomized, Multi-Center Extension Study to Evaluate Safety, Tolerability and Immunogenicity of a Third Dose of One of Four Different Formulations of rMenB + MenACWY in Adolescents Who Previously Received the Same Study Vaccines

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 440 (actual)
• Sponsor: Novartis Vaccines · Industry
• Sex: All
• Age: 11 Years – 18 Years
• Healthy volunteers: Accepted

Summary

This study will evaluate safety, tolerability, and immunogenicity of a booster dose of a meningococcal vaccine formulation in adolescents.

Conditions

• Meningococcal Disease
• Meningococcal Meningitis

Interventions

Type	Name	Description
BIOLOGICAL	Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate combined with meningococcal (group B) multicomponent recombinant vaccine	The lyophilized Meningococcal (groups A, C, W, and Y) oligosaccharide diphtheria CRM-197 conjugate vaccine reconstituted with one dose of Meningococcal (group B) multicomponent recombinant adsorbed vaccine
BIOLOGICAL	Meningococcal (group B) multicomponent recombinant adsorbed vaccine	Liquid Meningococcal (group B) multicomponent recombinant adsorbed vaccine
BIOLOGICAL	Tdap	Sterile liquid suspension of tetanus and diphtheria toxoids and acellular pertussis components intended for intramuscular injection

Timeline

• Start date: 2011-07-01
• Primary completion: 2012-01-01
• Completion: 2012-07-01
• First posted: 2011-06-06
• Last updated: 2014-11-19
• Results posted: 2014-11-19

Locations

7 sites across 3 countries: Chile, Colombia, Panama