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A Phase III randomi...
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Silfverdal, Sven-ArneUmeå universitet,Pediatrik
(författare)
A Phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at 2, 4, and 11-12 months
- Artikel/kapitelEngelska2016
Förlag, utgivningsår, omfång ...
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Elsevier BV,2016
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printrdacarrier
Nummerbeteckningar
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LIBRIS-ID:oai:DiVA.org:umu-125589
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https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-125589URI
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https://doi.org/10.1016/j.vaccine.2016.05.054DOI
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Språk:engelska
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Sammanfattning på:engelska
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Ämneskategori:ref swepub-contenttype
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Ämneskategori:art swepub-publicationtype
Anmärkningar
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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.
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Biuppslag (personer, institutioner, konferenser, titlar ...)
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Icardi, Giancarlo
(författare)
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Vesikari, Timo
(författare)
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Flores, Sheryl A.
(författare)
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Pagnoni, Marco F.
(författare)
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Xu, Jin
(författare)
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Liu, Frank
(författare)
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Stek, Jon E.
(författare)
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Boisnard, Florence
(författare)
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Thomas, Stephane
(författare)
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Ziani, Eddy
(författare)
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Lee, Andrew W.
(författare)
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Umeå universitetPediatrik
(creator_code:org_t)
Sammanhörande titlar
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Ingår i:Vaccine: Elsevier BV34:33, s. 3810-38160264-410X1873-2518
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Vaccine
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Silfverdal, Sven ...
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Icardi, Giancarl ...
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Vesikari, Timo
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Flores, Sheryl A ...
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Pagnoni, Marco F ...
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Xu, Jin
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Liu, Frank
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Stek, Jon E.
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Boisnard, Floren ...
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Thomas, Stephane
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Ziani, Eddy
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Lee, Andrew W.
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