Tetanus Clinical Trial
Official title:
Immunogenicity and Safety Study of GSK Biologicals' Boostrix™ Vaccine Using a New Syringe Presentation in Healthy Adolescents Aged 10-15 Years
The purpose of the study is to compare the immunogenicity and safety of a booster dose of BoostrixTM administered in a new syringe presentation to that of BoostrixTM administered in the previous syringe presentation in healthy adolescents aged 10-15 years.
The protocol has been updated following Protocol amendment 1 date 03 August 2011 leading to
the update of the exclusion criteria to allow subjects in Mexico to receive the flu vaccine
in accordance with the local standard of care.
The protocol has been updated following Protocol amendment 2 dated 14 December 2011 due to
the recruitment constraints as a result of the DT/dTpa vaccination campaign in the countries.
The inclusion and exclusion criteria were amended to allow the participation of those who
have already received the 6th dose of the diphtheria, tetanus and/or pertussis containing
vaccine.
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