Study title:
Double-blind, randomised, comparative, multicentre, clinical study to assess the immunogenicity and reactogenicity of three lots of SmithKline Beecham Biologicals' Haemophilus influenzae type b (Hib) tetanus conjugate vaccine when administered simultaneously with SmithKline Beecham Biologicals' tricomponent DTPa vaccine, reconstituted in one single injection, as a primary vaccination course in healthy infants at the age of 3 and 5 months (referred to in this report as Hib-10).
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: 208108/007 |
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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