Sökning: onr:"swepub:oai:DiVA.org:umu-125589" > A Phase III randomi...
Fältnamn | Indikatorer | Metadata |
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000 | 03916naa a2200505 4500 | |
001 | oai:DiVA.org:umu-125589 | |
003 | SwePub | |
008 | 160913s2016 | |||||||||||000 ||eng| | |
024 | 7 | a https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-1255892 URI |
024 | 7 | a https://doi.org/10.1016/j.vaccine.2016.05.0542 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 Silfverdal, Sven-Arneu Umeå universitet,Pediatrik4 aut0 (Swepub:umu)svar0002 |
245 | 1 0 | a A Phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at 2, 4, and 11-12 months |
264 | 1 | b Elsevier BV,c 2016 |
338 | a print2 rdacarrier | |
520 | a Background: Combination vaccines simplify vaccination visits and improve coverage and timeliness. DTaP5-HB-IPV-Hib is a new investigational, fully-liquid, combination vaccine designed to protect against 6 infectious diseases, including 5 pertussis antigens and OMPC instead of PT as conjugated protein for Hib component.Methods: In this multicenter, double-blind, comparator-controlled, Phase III study (NCT01480258) conducted in Sweden, Italy, and Finland, healthy infants were randomized 1:1 to receive one two immunization regimens. The DTaP5-HB-IPV-Hib Group received the investigational hexavalent vaccine (DTaP5-HB-IPV-Hib) and the Control Group received Infanrix-hexa (DTPa3-HBV-IPV/Hib) at 2, 4 and 11-12 months of age. Both groups received concomitantly Prevnar 13 (PCV13) and Rotateq (RV5) or Rotarix (RV1) at 2, 4 months of age and PCV13 at 11-12 months. Subjects administered RV5 received a 3rd dose at 5 months of age.Results: A total of 656 subjects were randomized to the DTaP5-HB-IPV-Hib Group and 659 subjects to Control Group. Immune responses to all vaccine antigens post-toddler dose were non-inferior in the DTaP5-HB-IPV-Hib Group as compared to the Control Group. Additionally, the post-dose 2 and pre-toddler DTaP5-HB-IPV-Hib anti-PRP responses were superior. The DTaP5-HB-IPV-Hib Group responses to concomitant RV1 were non-inferior compared to the Control Group. Solicited adverse event rates after any dose were similar in both groups, except for higher rates of pyrexia (6.4% difference; 95% CI: 1.5,11.3) and somnolence (5.8% difference; 95% CI: 1.7,9.8) in the DTaP5-HB-IPV-Hib Group. Vaccine-related serious adverse events occurred infrequently in the DTaP5-HB-IPV-Hib Group (0.3%) and the Control Group (0.5%).Conclusions: The safety and immunogenicity of DTaP5-HB-IPV-Hib is generally comparable to Control when administered in the 2, 4, 11-12 month schedule. Early Hib responses were superior versus Control. DTaP5-HB-IPV-Hib could provide a new hexavalent option for pediatric combination vaccines, aligned with recommended immunizations in Europe. | |
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 |
653 | a DTaP | |
653 | a Polio | |
653 | a Hib | |
653 | a Hepatitis B | |
653 | a Hexavalent | |
653 | a Vaccine | |
653 | a Safety | |
653 | a Immunogenicity | |
700 | 1 | a Icardi, Giancarlo4 aut |
700 | 1 | a Vesikari, Timo4 aut |
700 | 1 | a Flores, Sheryl A.4 aut |
700 | 1 | a Pagnoni, Marco F.4 aut |
700 | 1 | a Xu, Jin4 aut |
700 | 1 | a Liu, Frank4 aut |
700 | 1 | a Stek, Jon E.4 aut |
700 | 1 | a Boisnard, Florence4 aut |
700 | 1 | a Thomas, Stephane4 aut |
700 | 1 | a Ziani, Eddy4 aut |
700 | 1 | a Lee, Andrew W.4 aut |
710 | 2 | a Umeå universitetb Pediatrik4 org |
773 | 0 | t Vaccined : Elsevier BVg 34:33, s. 3810-3816q 34:33<3810-3816x 0264-410Xx 1873-2518 |
856 | 4 8 | u https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-125589 |
856 | 4 8 | u https://doi.org/10.1016/j.vaccine.2016.05.054 |
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