Study title: A phase IIb randomised, multi-site clinical study to assess the immunogenicity and reactogenicity of formulation B of SB Biologicals¿ Hib conjugate vaccine administered mixed as single injection with SB Biologicals¿ DTPa vaccine versus formulation A of SB Biologicals¿ Hib conjugate vaccine administered either mixed as single injection or separately into opposite thighs with SB Biologicals¿ DTPa vaccine as a three-dose primary vaccination course in healthy infants at 3, 4, and 5 months of age.
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: 208108/045 | |||||
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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