A Phase III randomized, double-blind, clinical trial of an investigational hexavalent vaccine given at 2, 4, and 11-12 months

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Fältnamn	Indikatorer	Metadata
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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Av författaren/redakt...: Silfverdal, Sven ...; Icardi, Giancarl ...; Vesikari, Timo; Flores, Sheryl A ...; Pagnoni, Marco F ...; Xu, Jin; visa fler...; Liu, Frank; Stek, Jon E.; Boisnard, Floren ...; Thomas, Stephane; Ziani, Eddy; Lee, Andrew W.; visa färre...

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Av lärosätet: Umeå universitet

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