Study title:
Open, randomized clinical study of the immunogenicity and reactogenicity of the SB Biologicals¿ DTPa and Hib conjugate vaccines, either mixed in one syringe or given in two separate injections, to healthy infants at the age of 2, 4, 6 and 18 months, or the administration of a dose of plain PRP at the age of 12 months in infants primed with Hib conjugate vaccine.
Type of medicine: Non-centrally authorised vaccines
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Therapeutic area: Bacterial Infections and Mycoses [01]
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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:
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Document date: 2011-09-23
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Study number: 208108/027 |
EudraCT number:
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Scope of study: CLINICAL |
Population of study subjects:
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Preterm newborn Infants
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Newborn infants
(1 to 27 days)
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Infants and toddlers
(28 days to 24 months)
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Children
(2 to 11 years)
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Adolescents
(12 to 18 years)
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-
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-
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Y
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-
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-
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