Study title: An open, randomised clinical study to assess the reactogenicity of SB Biologicals¿ Hib conjugate vaccine administered mixed as single injection with SB Biologicals¿ DTPa vaccine in comparison to commercially available Hib conjugate vaccine and DTPw vaccine administered separately into opposite limbs as a booster vaccination in healthy infants at 18 months of age, previously primed with three doses of DTPw and Hib conjugate vaccines.
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: 208108/049 | |||||
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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