Study title: An open, randomised post-marketing clinical trial to assess the safety and reactogenicity of GlaxoSmithKline Biologicals¿ Haemophilus influenzae type b (Hib) tetanus conjugate vaccine (Hiberix¿) co-administered with Chinese local DTPw vaccine when compared to Chinese local DTPw vaccine administered alone, in healthy infants at 3, 4 and 5 months of age.
Type of medicine: Non-centrally authorised vaccines | |||||
Therapeutic area: Virus Diseases [C02] | |||||
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/ J07AG50 | |||||
Document link: | |||||
Document date: 2011-09-23 | |||||
Study number: 104124/ETR | |||||
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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