Clinical Trial: Immunogenicity of the Booster Dose of Two MenC Vaccines
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: 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
Brief 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 Summary: 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.
Sponsor: Centro Superior de Investigación en Salud Publica
Current Primary Outcome:
- Serum Bactericidal Activity Against MenC [ Time Frame: One month after booster dose ]
- Serum Antibody Titers Against Haemophilus Influenzae Type b. [ Time Frame: One year ]
Original Primary Outcome:
- Serum Bactericidal Activity Against MenC
- Serum Antibody Titers Against Haemophilus Influenzae Type b.
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Centro Superior de Investigación en Salud Publica
Dates:
Date Received: October 25, 2006
Date Started: January 2007
Date Completion:
Last Updated: August 6, 2013
Last Verified: August 2013
