Sökning: onr:"swepub:oai:DiVA.org:umu-131092" > A Randomized, Contr...
Fältnamn | Indikatorer | Metadata |
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000 | 03441naa a2200385 4500 | |
001 | oai:DiVA.org:umu-131092 | |
003 | SwePub | |
008 | 170215s2017 | |||||||||||000 ||eng| | |
024 | 7 | a https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-1310922 URI |
024 | 7 | a https://doi.org/10.1097/INF.00000000000013582 DOI |
040 | a (SwePub)umu | |
041 | a engb eng | |
042 | 9 SwePub | |
072 | 7 | a ref2 swepub-contenttype |
072 | 7 | a art2 swepub-publicationtype |
100 | 1 | a Vesikari, Timo4 aut |
245 | 1 0 | a A Randomized, Controlled Study of DTaP-IPV-HB-PRP-T, a Fully Liquid Hexavalent Vaccine, Administered in a 3-,5-and 11-to 12-month Schedule |
264 | 1 | c 2017 |
338 | a print2 rdacarrier | |
520 | a Background: To assess the immunogenicity and safety of a fully liquid, ready-to-use hexavalent DTaP-IPV-HB-PRP-T vaccine when administered in a 2 + 1 schedule at 3, 5 and 11-12 months of age.Methods: Phase III, randomized, active-controlled, observer-blind, multi-center study. Infants were randomized to receive DTaP-IPV-HB-PRP-T (N = 275) or a licensed control hexavalent vaccine (DTaP-IPV-HB//PRPNT: N = 275), both given in coadministration with Prevenar 13. Serum was analyzed for immune responses to all vaccine antigens. Noninferiority of DTaP-IPV-HB-PRP-T to the control vaccine was tested at completion of the primary series using predefined seroprotection (SP) rate and vaccine response (VR) rates. Safety was assessed using parental reports.Results: Noninferiority of DTaP-IPV-HB-PRP-T to the control vaccine was demonstrated postdose 3 for each antigen, and the SP (for D, T, poliovirus 1, 2 and 3, hepatitis B and polyribosylribitol phosphate) and VR rates (for pertussis toxin and filamentous hemagglutinin) were high in each group. SP rates for D, T, polio 1, 2, 3 and VR rates for pertussis toxin and filamentous hemagglutinin were similar in each group. For hepatitis B, SP rate was slightly higher for DTaP-IPV-HB//PRP similar to T (99.6%) than DTaP-IPV-HB-PRP-T (96.4%), and for PRP, SP rate was higher for DTaP-IPV-HB-PRP-T (93.5%) than DTaP-IPV-HB//PRP similar to T (85.2%). For Prevenar 13, the SP rate was high for each serotype and similar for both groups. All vaccines were well tolerated.Conclusions: These study findings confirm the safety and immunogenicity and thus the suitability of this fully liquid hexavalent vaccine for administration in a 2 + 1 schedule. | |
650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Klinisk medicinx Pediatrik0 (SwePub)302212 hsv//swe |
650 | 7 | a MEDICAL AND HEALTH SCIENCESx Clinical Medicinex Pediatrics0 (SwePub)302212 hsv//eng |
650 | 7 | a MEDICIN OCH HÄLSOVETENSKAPx Medicinska och farmaceutiska grundvetenskaperx Immunologi inom det medicinska området0 (SwePub)301102 hsv//swe |
650 | 7 | a MEDICAL AND HEALTH SCIENCESx Basic Medicinex Immunology in the medical area0 (SwePub)301102 hsv//eng |
653 | a hexavalent vaccine | |
653 | a 2+1 schedule | |
653 | a immunogenicity | |
653 | a safety | |
700 | 1 | a Silfverdal, Sven-Arneu Umeå universitet,Pediatrik4 aut0 (Swepub:umu)svar0002 |
700 | 1 | a Jordanov, Emilia4 aut |
700 | 1 | a Feroldi, Emmanuel4 aut |
710 | 2 | a Umeå universitetb Pediatrik4 org |
773 | 0 | t The Pediatric Infectious Disease Journalg 36:1, s. 87-93q 36:1<87-93x 0891-3668x 1532-0987 |
856 | 4 8 | u https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-131092 |
856 | 4 8 | u https://doi.org/10.1097/INF.0000000000001358 |
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