Study title:
EUV07: A phase III, open, randomized, controlled, primary vaccination study to assess the immunogenicity and the safety of CP20/20/5/3DT-IPV-PRP~T and ACTAcel given concomitantly with OPV vaccine and TETRAct-Hib given concomitantly with OPV vaccine at 6, 10, 14 weeks of age. All infants receiving hepatitis B vaccine (Recomvax B) at 0, 6, 14 weeks of age
EUV06: Safety and immunogenicity of hepatitis B vaccine distributed by Aventis Pasteur Korea administered at 0-1-6 months when given in association with three Aventis Pasteur pertussis combination (1 whole cell and 2 acellular) vaccines administered at 2, 4 and 6 months in Mexican infants
Type of medicine: Non-centrally authorised vaccines
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Therapeutic area: Virus Diseases
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Brands: |
MAH holders: |
Assessment: |
Active substance: Hepatitis B Surface Antigen |
ATC code: |
Document link:
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Document date: 2011-09-16
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Study number: AVP_EUV06 & AVP_EUV07 |
EudraCT number:
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Scope of study: |
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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Y
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-
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-
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-
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