Safety and Efficacy of a Pentavalent Human–Bovine (WC3) Reassortant Rotavirus Vaccine

Vesikari, Timo; Matson, David O.; Dennehy, Penelope H.; Damme, Pierre Van; Santosham, Mathuram; Rodriguez, Zoe; Dallas, Michael J.; Heyse, Joseph F.; Goveia, Michelle G.; Black, Steven; Shinefield, Henry R.; Christie, Celia D. C.; Ylitalo, Samuli; Itzler, Robbin; Coia, Michele L; Onorato, Matthew T.; Adeyi, Ben; Marshall, Gary S.; Gothefors, Leif; Campens, Dirk; Karvonen, Aino; Watt, James; O'Brien, Katherine L.; DiNubile, Mark J.; Clark, H Fred; Boslego, John W.; Offit, Paul A.; Heaton, Penny M.

doi:10.1056/nejmoa052664

Cited by 1,692 publications

(1,373 citation statements)

References 31 publications

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“…During the study until the end of the 2003-2004 winter season the G1;P [8] genotype was widespread while G9:P [8] remained rare. A majority of severe rotavirus gastroenteritis requiring hospitalization may be prevented by the widespread use of rotavirus vaccines [52][53][54]. Noroviruses are the second leading causative agent of gastroenteritis in hospitalized young children and such infections are less severe than those caused by rotavirus.…”

Section: Discussionmentioning

confidence: 99%

Epidemiology and clinical features of gastroenteritis in hospitalised children: prospective survey during a 2-year period in a Parisian hospital, France

Lorrot

Bon

Hajje

et al. 2010

Eur J Clin Microbiol Infect Dis

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International audienceRotavirus is recognised as the most important agent of severe acute gastroenteritis (AGE) in young children. In a 2-year prospective survey, we investigated the epidemiology and clinical features of the viral and bacterial pathogens in children hospitalised for AGE. The study was performed in a Parisian teaching hospital from November 2001 to May 2004. Clinical data were prospectively collected to assess the gastroenteritis severity (20-point Vesikari severity score, the need for intravenous rehydration, duration of hospitalisation). Stools were systematically tested for group A rotavirus, norovirus, astrovirus and adenovirus 40/41, sapovirus and Aichi virus and enteropathogenic bacteria. A total of 457 children (mean age 15.9 months) were enrolled. Viruses were detected in 305 cases (66.7%) and bacteria in 31 cases (6.8%). Rotaviruses were the most frequent pathogen (48.8%), followed by noroviruses (8.3%) and adenoviruses, astroviruses, Aichi viruses and sapoviruses in 3.5%, 1.5%, 0.9% and 0.4%, respectively. Cases of rotavirus gastroenteritis were significantly more severe than those of norovirus with respect to the Vesikari score, duration of hospitalisation and the need for intravenous rehydration. Rotaviruses were the most frequent and most severe cause in children hospitalised for AGE, and noroviruses also account for a large number of cases in this population

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Section: Discussionmentioning

confidence: 99%

Epidemiology and clinical features of gastroenteritis in hospitalised children: prospective survey during a 2-year period in a Parisian hospital, France

Lorrot

Bon

Hajje

et al. 2010

Eur J Clin Microbiol Infect Dis

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“…Two of the largest clinical trials in history showed that these vaccines are safe and highly effective for preventing life-threatening dehydrating rotavirus diarrhea, providing either serotype-specific or crossreactive protective immune responses [24,25].…”

Section: Introductionmentioning

confidence: 99%

Molecular epidemiology of rotaviruses in Bulgaria: annual shift of the predominant genotype

Mladenova

Korsun²,

Geonova³

et al. 2010

Eur J Clin Microbiol Infect Dis

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“…Some preliminary data are available from the U.S., where a live, oral pentavalent rotavirus vaccine (RV5) was introduced in 2006: Vaccine coverage has been estimated at 58% for children aged 3 months (1 dose [8]. The pentavalent vaccine RotaTeq has been estimated to have an efficacy over the first season post-inoculation of 98% against severe forms of rotavirus gastroenteritis [40]. For another vaccine, Rotarix, which was the first approved for use in Europe, approximately 96% of severe infections were prevented in the first year (information from the Rotarix drug label).…”

Section: Vaccinationmentioning

confidence: 99%

“…Many studies have already dealt with the need for safe and effective vaccines to reduce morbidity and mortality caused by rotavirus gastroenteritis in children [3,31,40]. But few studies have focused specifically on other simple preventive measures which could be applied to control nosocomial epidemic risk for pediatric rotavirus outbreaks, like hand washing or disinfection, although their effectiveness has been proven [18].…”

Section: Introductionmentioning

confidence: 99%

Modeling Nosocomial Transmission of Rotavirus in Pediatric Wards

et al. 2010

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Nosocomial transmission of viral and bacterial infections is a major problem worldwide, affecting millions of patients (and causing hundreds of thousands of deaths) per year. Rotavirus infections affect most children worldwide at least once before age five. We present here deterministic and stochastic models for the transmission of rotavirus in a pediatric hospital ward and draw on published data to compare the efficacy of several possible control measures in reducing the number of infections during a 90-day outbreak, including cohorting, changes in healthcare worker-patient ratio, improving compliance with preventive hygiene measures, and vaccination. Although recently approved vaccines have potential to curtail most nosocomial rotavirus transmission in the future, even short-term improvement in preventive hygiene compliance following contact with symptomatic patients may significantly limit transmission as well, and remains an important control measure, especially where resources are limited.

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Safety and Efficacy of a Pentavalent Human–Bovine (WC3) Reassortant Rotavirus Vaccine

Abstract: 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.)

Cited by 1,692 publications

References 31 publications

Epidemiology and clinical features of gastroenteritis in hospitalised children: prospective survey during a 2-year period in a Parisian hospital, France

Epidemiology and clinical features of gastroenteritis in hospitalised children: prospective survey during a 2-year period in a Parisian hospital, France

Molecular epidemiology of rotaviruses in Bulgaria: annual shift of the predominant genotype

Modeling Nosocomial Transmission of Rotavirus in Pediatric Wards

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