The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of a booster dose of the candidate Hib-MenC conjugate vaccine given concomitantly with measles, mumps and rubella (MMR) vaccine, versus Hib-MenC only and MMR only, when given to healthy subjects aged 13 to 14 months who were primed with 3 doses of Hib (as part of a DTPa -containing vaccine) and MenC-CRM197.
This multicenter study is open with respect to the treatment allocation, but double-blind with respect to the Hib-MenC-TT lots (3 lots). Hib-MenC-TT and Priorix™, when given separately, serve as active controls. Two blood samples are taken: before and one month after vaccination. Additional vaccines are offered at study end in order to complete the vaccine schedule recommended in Spain
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
297
GSK Investigational Site
Almería, Spain
GSK Investigational Site
Almería, Spain
GSK Investigational Site
Antequera/Málaga, Spain
GSK Investigational Site
Aravaca, Spain
GSK Investigational Site
Blanes, Spain
GSK Investigational Site
Burgos, Spain
GSK Investigational Site
Lleida, Spain
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Madrid, Spain
GSK Investigational Site
Marbella, Spain
...and 6 more locations
Any grade 3 solicited symptoms (d 0 - 3)
Sol (d 0-3, local & general), unsol & MMR specific (d 0-42) symptoms. SAEs (whole study). Subjects with Hib-MenC (pre&42 d post vacc): SBA-MenC titers, anti-PRP, -PSC conc. Subjects with MMR (42 d post vacc): anti-measles, -mumps, -rubella seroconversion
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