Study title: Clinical study to assess the immunogenicity and reactogenicity of a booster dose of formulation B of SB Biologicals¿ Hib conjugate vaccine administered either mixed as a single injection or separate into opposite sites with SB Biologicals¿ DTPa vaccine, or formulation A of SB Biologicals¿ Hib conjugate vaccine separately into opposite sites with SB Biologicals¿ DTPa vaccine at 13 months of age in infants primed in study 208108/032 (Hib-032).
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: 208108/050 | |||||
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) |
- | - | Y | - | - |