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DTPw-HBV/Hib (n=439)

Primary vaccination study. 585 enrolled and vaccinated. DTPw-HBV/Hib (n=439). Tritanrix -HBV/Hib (n=146). 8 subjects dropped out: 1 non-serious AE 4 protocol violations 2 consent withdrawals 1 moved away. 22 subjects dropped out:

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DTPw-HBV/Hib (n=439)

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  1. Primary vaccination study 585 enrolled and vaccinated DTPw-HBV/Hib (n=439) Tritanrix-HBV/Hib (n=146) 8 subjects dropped out: 1 non-serious AE 4 protocol violations 2 consent withdrawals 1 moved away 22 subjects dropped out: 1 SAE 1 non-serious AE 2 protocol violations 11 consent withdrawals 5 moved away 2 lost to follow-up 417 completed 138 completed 439 total vaccinated cohort 146 total vaccinated cohort 39 exclusions: 2 administration of forbidden vaccines 10 study vaccine not administered according to protocol 5 non-compliance with vaccination schedule 1 non-compliance with blood sampling schedule 21 essential serological data missing 14 exclusions: 1 administration of forbidden vaccines 3 study vaccine not administered according to protocol 1 non-compliance with blood sampling schedule 9 essential serological data missing 400 ATP cohort for immunogenicity 132 ATP cohort for immunogenicity Booster study 147 enrolled and vaccinated DTPw-HBV/Hib n=113 Tritanrix-HBV/Hib n=34 113 completed 34 completed 113 total vaccinated cohort 34 total vaccinated cohort 3 exclusions: 1 study vaccine not administered ATP 1 essential serological data missing 110 ATP cohort for immunogenicity 34 ATP cohort for immunogenicity

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