A second dose of a measles-mumps-rubella vaccine administered to healthy four-to-six-year-old children: a phase III, observer-blind, randomized, safety and immunogenicity study comparing GSK MMR and MMR II with and without DTaP-IPV and varicella vaccines co-administration
- 주제(키워드) Measles-mumps-rubella vaccine , DTaP-IPV , varicella vaccine , immunogenicity , safety , co-administration
- 주제(기타) Biotechnology & Applied Microbiology; Immunology
- 설명문(일반) [Gillard, Paul; Povey, Michael] GSK, 20 Ave Fleming, B-1300 Wavre, Belgium; [Chiu Nan-Chang] Mackay Mem Hosp, 92 Sec 2,Zhongshan N Rd, Taipei, Taiwan; [Clifford, Robert] Coastal Pediat Associates, 2051 Charlie Hall Blvd, Charleston, SC 29414 USA; [Huang Li-Min] Natl Taiwan Univ, Dept Pediat, 8 Chung Shan South Rd, Taipei, Taiwan; [Huang Yhu-Chering] Chang Gung Mem Hosp, 5 Fu Hsing St, Taoyuan, Taiwan; [Jo, Dae Sun] Chonbuk Natl Univ, Childrens Hosp, Dept Pediat, 20 Geonji Ro, Jeonju, South Korea; [Kim, Chun Soo] Keimyung Univ, Sch Med, 194 Dongsan Dong, Daegu, South Korea; [Kim, Hwang Min] Wonju Christian Hosp, Pediat, 162 Ilsan Dong, Wonju, Kangwon Do, South Korea; [Kim, Kwang-Nam] Hallym Univ, Sacred Heart Hosp, 896 Pyeongchon Dong, Anyang Si, Gyeonggi Do, South Korea; [Kim, Kyung-Hyo] Ewha Womans Univ, Coll Med, Dept Pediat, 1071 Anyangcheon Ro, Seoul, South Korea; [Kim, Yun-Kyung] Korea Univ, Ansan Hosp, 516,Gojan1 Dong, Ansan, South Korea; [Klein, Nicola P.] Kaiser Permanente Vaccine Study Ctr, 1 Kaiser Plaza, Oakland, CA USA; [Ma, Sang-Hyuk] Changwon Fatima Hosp, 212 MyeongSeo Dong, Chang Won, Gyeongsangnam D, South Korea; [Peltier, Christopher] Univ Cincinnati, Coll Med, Dept Pediat, 4371 Ferguson Dr, Cincinnati, OH 45245 USA; [Peltier, Christopher] Pediat Associates Mt Carmel Inc, 4371 Ferguson Dr, Cincinnati, OH 45245 USA; [Senders, Shelly] Senders Pediat, 2054 South Green Rd, Cleveland, OH 44121 USA; [Shepard, Julie] Ohio Pediat Res Assoc, Suite 200,7200 Poe Ave, Dayton, OH 45414 USA; [Wu, Tsung Zu] Taipei City Hosp, Heping Fuyou Branch, Dept Pediat, 12 Fuzhou St, Taipei, Taiwan; [Yeh, Shu Jen] Far Eastern Mem Hosp, 21,Sec 2,Nanya S Rd, New Taipei, Taiwan; [Zissman, Edward] Altamonte Pediat Associates, Suite 1100,475 Osceola St, Altamonte Springs, FL 32701 USA; [Abu-Elyazeed, Remon] GSK, 5 Crescent Dr, Philadelphia, PA 19112 USA; [Henry, Ouzama] GSK, 14200 Shady Grove Rd, Rockville, MD 20850 USA
- 등재 SCIE, SCOPUS
- OA유형 Green Published, Bronze
- 발행기관 TAYLOR & FRANCIS INC
- 발행년도 2019
- URI http://www.dcollection.net/handler/ewha/000000159762
- 본문언어 영어
- Published As http://dx.doi.org/10.1080/21645515.2018.1554971
- PubMed https://pubmed.ncbi.nlm.nih.gov/30785357
초록/요약
In many countries, a second dose of a combined measles, mumps, and rubella (MMR) vaccine is recommended at 4-6 years of age - similarly to the booster of diphtheria, tetanus, acellular pertussis, and inactivated polio vaccine (DTaP-IPV) and the second dose of varicella vaccine (VV). Vaccine co-administration is generally encouraged if no interferences exist among the vaccines. This phase IIIa, randomized, controlled trial (NCT01621802) evaluated the immunogenicity and safety of MMR-RIT (Priorix, GSK) when given as a second dose with or without co-administration of DTaP-IPV and VV, using MMR II (M-M-R II, Merck & Co Inc.) as comparator. Antibody geometric mean concentrations or titers (GMCs/GMTs) and response rates to the components of all the administered vaccines were assessed. Solicited, unsolicited, and serious adverse events were recorded. Four thousand eleven children aged 4-6 years were enrolled. MMR-RIT elicited immune responses that were not inferior to those of MMR II in terms of GMCs and seroresponse rates when administered alone or when co-administered with DTaP-IPV and VV. The immune responses to the co-administered vaccines in MMR-RIT recipients were non-inferior to those in MMR II recipients. MMR-RIT and MMR II demonstrated similar reactogenicity profiles; the most frequent solicited adverse events across vaccine groups and sub-cohorts were local pain and fever. In conclusion, the immunogenicity and safety profiles of MMR-RIT administered with or without DTaP-IPV and VV were similar to those of MMR II.
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