NCT00392808

Immunogenicity of the Booster Dose of Two MenC Vaccines

Randomized, Open Label, Active Control, Parallel Assignment Clinical Trial to Evaluate the Immunogenicity of Polysaccharide Meningococcal C Vaccines Conjugated With Tetanus Toxoid or CRM197 Given as a Booster Dose at 14-18 Months of Life.

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 389 (actual)
• Sponsor: Centro Superior de Investigación en Salud Publica · Other Government
• Sex: All
• Age: 14 Months – 19 Months
• Healthy volunteers: Accepted

Summary

The purpose of the study is to evaluate the immune response of toddlers, to a booster dose in the second year of life of two meningococcal C conjugated polysaccharide vaccine, and to assess the interchangeability of the two different vaccines.

Detailed description

Children 14 to 18 months of life, previously vaccinated with 2 doses of tetanus toxoid conjugated polysaccharide men C vaccine or three doses of the CRM197 conjugated polysaccharide men C vaccine before 7 months of age, are randomized to receive any of the two vaccines. Serum antibody activity against meningococcus C will be measured inmediately before and 4 weeks after the booster dose. Children will also be vaccinated with a combined vaccine containing DTaP+IPV+Hib.

Conditions

• Meningococcal Infection

Interventions

Type	Name	Description
BIOLOGICAL	conjugated polysaccharide menC vaccine	Booster vaccine dose at 14 to 18 months.

Timeline

• Start date: 2007-01-01
• Primary completion: 2008-05-01
• Completion: 2009-05-01
• First posted: 2006-10-26
• Last updated: 2013-10-11
• Results posted: 2013-10-11

Locations

2 sites across 1 country: Spain