Study of a Booster Dose of Hib-MenC Conjugate Vaccine vs Infanrix Hexa When Given to 14 Month Old Subjects
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The purpose of this study is to evaluate the immunogenicity, safety and reactogenicity of a booster dose of the Hib-MenC conjugate vaccine when given to healthy subjects aged 13 to 14 months who were primed with three doses of Hib-MenC compared to a booster dose of Infanrix hexa given to subjects primed with three doses of Infanrix hexa and Meningitec.
Condition or disease
Neisseria MeningitidisHaemophilus Influenzae Type b
Biological: Haemophilus influenzae type b- and meningococcal (vaccine)
The study is open and Infanrix hexa will serve as active control. Subjects will receive one vaccine dose of either Hib-MenC or Infanrix hexa, and will have 2 blood samples taken: before and one month after vaccination. Subjects who will receive a booster dose of Hib-MenC were primed with 3 doses of Infanrix penta + Hib-MenC or 2 doses of NeisVac-C and Infanrix hexa / Infanrix IPV/Hib.
Evaluate Immunogenicity,Safety & Reactogenicity of a Booster Dose of Hib-MenC Conjugate Vaccine When Given to Healthy Subjects Aged 13-14 Months Who Were Primed With 3 Doses of Hib-MenC vs a Booster Dose of Infanrix Hexa Given to Subjects Primed With 3 Doses of Infanrix Hexa and Meningitec
Study Start Date :
Actual Primary Completion Date :
Actual Study Completion Date :
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Layout table for eligibility information
Ages Eligible for Study:
13 Months to 14 Months (Child)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy male or female between, and including, 13 and 14 months of age
Having participated in the primary vaccination study 217744/097.
Previous vaccination against OR history of OR known exposure to diphtheria, tetanus, pertussis, hepatitis B, polio, H. influenzae type b (Hib) and/or meningococcal serogroup C disease except if within the framework of study 217744/097
Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
A family history of congenital or hereditary immunodeficiency