2007
DOI: 10.4161/hv.3.5.4352
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A Retrospective Study on the Quality of Haemophilus Influenzae Type B Vaccines Used in the U.K. Between 1996 and 2004

Abstract: Following the reduction in efficacy of Hib-TT vaccines in the primary immunization schedule observed in the UK between 1999 and 2003, batches of vaccine manufactured by two different companies were retrospectively examined by the National Institute for Biological Standards and Control. The study evaluated 41 batches of the Hib-TT vaccines manufactured between 1994 and 2003, assaying potency (total PRP saccharide content), integrity (% free saccharide), consistency (molecular sizing), and immunogenicity, as wel… Show more

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Cited by 11 publications
(5 citation statements)
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“…1 ). All of the TT conjugates were polydisperse as previously observed [19,21–23] with Mw/Mn up to 2.3.…”
Section: Resultssupporting
confidence: 79%
“…1 ). All of the TT conjugates were polydisperse as previously observed [19,21–23] with Mw/Mn up to 2.3.…”
Section: Resultssupporting
confidence: 79%
“…Indeed, FtO-PS conjugates synthesized and affinity-purified from detoxified iVAX lysates contained 0.21 ± 0.3 EU per 10-g dose, which is well below endotoxin levels reported in commercial conjugate vaccines (<12 EU/dose) (Fig. 5D) (63,67).…”
Section: Endotoxin Editing and Freeze-drying Yield Ivax Reactions Tha...mentioning
confidence: 63%
“…It is thus unlikely that the total CRM content of a vaccine, or of a series of vaccinations, is the sole source of interference in Hib antibody responses and other causes need to be considered. with only 2.60 x10 6 g/mol for the 3 component vaccine [23,24]. The 5 component vaccine also has a lower total PRP saccharide content [23].…”
Section: Discussionmentioning
confidence: 99%
“…with only 2.60 x10 6 g/mol for the 3 component vaccine [23,24]. The 5 component vaccine also has a lower total PRP saccharide content [23]. In addition, the 3 component vaccine also contains hepatitis B.…”
Section: Discussionmentioning
confidence: 99%