WFRF:(Henry S M)
Sökning: WFRF:(Henry S M) > (2005-2009) > Safety and efficacy...
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| Fältnamn | Indikatorer | Metadata |
|---|---|---|
| 000 | 04792naa a2200841 4500 | |
| 001 | oai:DiVA.org:umu-6994 | |
| 003 | SwePub | |
| 008 | 080112s2006 | |||||||||||000 ||eng| | |
| 024 | 7 | a https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-69942 URI |
| 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 Safety and efficacy of a pentavalent human-bovine (WC3) reassortant rotavirus vaccine. |
| 264 | 1 | c 2006 |
| 338 | a print2 rdacarrier | |
| 520 | a BACKGROUND: Rotavirus is a leading cause of childhood gastroenteritis and death worldwide. METHODS: We studied healthy infants approximately 6 to 12 weeks old who were randomly assigned to receive three oral doses of live pentavalent human-bovine (WC3 strain) reassortant rotavirus vaccine containing human serotypes G1, G2, G3, G4, and P[8] or placebo at 4-to-10-week intervals in a blinded fashion. Active surveillance was used to identify subjects with serious adverse and other events. RESULTS: The 34,035 infants in the vaccine group and 34,003 in the placebo group were monitored for serious adverse events. Intussusception occurred in 12 vaccine recipients and 15 placebo recipients within one year after the first dose including six vaccine recipients and five placebo recipients within 42 days after any dose (relative risk, 1.6; 95 percent confidence interval, 0.4 to 6.4). The vaccine reduced hospitalizations and emergency department visits related to G1-G4 rotavirus gastroenteritis occurring 14 or more days after the third dose by 94.5 percent (95 percent confidence interval, 91.2 to 96.6 percent). In a nested substudy, efficacy against any G1-G4 rotavirus gastroenteritis through the first full rotavirus season after vaccination was 74.0 percent (95 percent confidence interval, 66.8 to 79.9 percent); efficacy against severe gastroenteritis was 98.0 percent (95 percent confidence interval, 88.3 to 100 percent). The vaccine reduced clinic visits for G1-G4 rotavirus gastroenteritis by 86.0 percent (95 percent confidence interval, 73.9 to 92.5 percent). CONCLUSIONS: This vaccine was efficacious in preventing rotavirus gastroenteritis, decreasing severe disease and health care contacts. The risk of intussusception was similar in vaccine and placebo recipients. (ClinicalTrials.gov number, NCT00090233.) Copyright 2006 Massachusetts Medical Society. | |
| 653 | a Administration; Oral | |
| 653 | a Animals | |
| 653 | a Antibodies; Viral/blood | |
| 653 | a Cattle | |
| 653 | a Diarrhea; Infantile/prevention & control/virology | |
| 653 | a Double-Blind Method | |
| 653 | a Female | |
| 653 | a Fever/etiology | |
| 653 | a Gastroenteritis/*prevention & control/virology | |
| 653 | a Gastrointestinal Hemorrhage/etiology | |
| 653 | a Health Resources/utilization | |
| 653 | a Hospitalization | |
| 653 | a Humans | |
| 653 | a Immunoglobulin A/blood | |
| 653 | a Infant | |
| 653 | a Intussusception/*etiology | |
| 653 | a Male | |
| 653 | a Reassortant Viruses | |
| 653 | a Risk | |
| 653 | a Rotavirus/classification/immunology | |
| 653 | a Rotavirus Infections/*prevention & control | |
| 653 | a Rotavirus Vaccines/administration & dosage/adverse effects/immunology | |
| 653 | a Vaccines; Attenuated/administration & dosage/adverse effects/immunology | |
| 700 | 1 | a Matson, David O4 aut |
| 700 | 1 | a Dennehy, Penelope4 aut |
| 700 | 1 | a Van Damme, Pierre4 aut |
| 700 | 1 | a Santosham, Mathuram4 aut |
| 700 | 1 | a Rodriguez, Zoe4 aut |
| 700 | 1 | a Dallas, Michael J4 aut |
| 700 | 1 | a Heyse, Joseph F4 aut |
| 700 | 1 | a Goveia, Michelle G4 aut |
| 700 | 1 | a Black, Steven B4 aut |
| 700 | 1 | a Shinefield, Henry R4 aut |
| 700 | 1 | a Christie, Celia D C4 aut |
| 700 | 1 | a Ylitalo, Samuli4 aut |
| 700 | 1 | a Itzler, Robbin F4 aut |
| 700 | 1 | a Coia, Michele L4 aut |
| 700 | 1 | a Onorato, Matthew T4 aut |
| 700 | 1 | a Adeyi, Ben A4 aut |
| 700 | 1 | a Marshall, Gary S4 aut |
| 700 | 1 | a Gothefors, Leifu Umeå universitet,Pediatrik4 aut0 (Swepub:umu)lego0001 |
| 700 | 1 | a Campens, Dirk4 aut |
| 700 | 1 | a Karvonen, Aino4 aut |
| 700 | 1 | a Watt, James P4 aut |
| 700 | 1 | a O'Brien, Katherine L4 aut |
| 700 | 1 | a DiNubile, Mark J4 aut |
| 700 | 1 | a Clark, H Fred4 aut |
| 700 | 1 | a Boslego, John W4 aut |
| 700 | 1 | a Offit, Paul A4 aut |
| 700 | 1 | a Heaton, Penny M4 aut |
| 710 | 2 | a Umeå universitetb Pediatrik4 org |
| 773 | 0 | t N Engl J Medg 354:1, s. 23-33q 354:1<23-33x 1533-4406 |
| 856 | 4 | u http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?db=PubMed&cmd=Retrieve&list_uids=16394299&dopt=Citation |
| 856 | 4 8 | u https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-6994 |
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