Study title: Open clinical study to evaluate persistence of antibodies induced by a primary vaccination course using SmithKline Beecham Biologicals¿ Hib vaccine mixed with SmithKline Beecham Biologicals' DTPa vaccine, and to assess immunogenicity and reactogenicity of a booster dose of the same vaccines at 15-20 months of age (referred to in this report as Hib-21).
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: | |||||
Study number: 208108/021 | |||||
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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