Study title: Randomised, double-blind clinical study to evaluate and compare the immunogenicity and reactogenicity of a booster dose of two formulations of SB Biologicals' Hib conjugate vaccine, when administered mixed in one syringe with SB Biologicals' DTPa vaccine to healthy children in their 2nd year of life.
Type of medicine: Non-centrally authorised vaccines | |||||
Therapeutic area: Bacterial Infections and Mycoses [01] | |||||
Brands: Please see report, Please see report, Please see report | |||||
MAH holders: Please see report | |||||
Assessment: | |||||
Active substance: Haemophilus influenzae type b capsular polysaccharide (PRP) conjugated to tetanus toxoid (TT) | |||||
ATC code: J07AG01/ J07AG51 | |||||
Document link: | |||||
Document date: 2011-09-23 | |||||
Study number: 208108/031 | |||||
EudraCT number: | |||||
Scope of study: CLINICAL | |||||
Population of study subjects: | Preterm newborn Infants | Newborn infants (1 to 27 days) | Infants and toddlers (28 days to 24 months) | Children (2 to 11 years) | Adolescents (12 to 18 years) |
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