Study title:
A phase II, open-label, randomized, single-center, comparative study evaluating safety, tolerability and immunogenicity of three vaccinations of the DTPHib combined vaccine (Chiron Vaccines; now Novartis Vaccines) in comparison to separate vaccinations of DTP (Chiron Behring; now Novartis Vaccines) and Hib/AlPO4 (Chiron Vaccines; now Novartis Vaccines) vaccines, when administered to 2, 3, 4 months old healthy infants.Please see report- sturdy report
Type of medicine: Non-centrally authorised vaccines
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Therapeutic area: Bacterial Infections and Mycoses
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Brands: Please see report |
MAH holders: Please see report |
Assessment: |
Active substance: Diphtheria, Tetanus and Pertussis Vaccine (Adsorbed) |
ATC code: J07AJ01 |
Document link:
V38P1.xlsx
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Document date: 2015-02-26
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Study number: V38P1 |
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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