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.)
Concerns about adequate protection of children's health from chemicals in the environment have created a need for research to identify how children's risks differ from adults'. A systematic review of factors that affect child sensitivity throughout development may be useful for research and practice in this area. We summarized available literature and other peer-reviewed information on factors that affect pharmacokinetics and exposure in an age-based developmental framework. Biological processes related to chemical absorption (gastrointestinal, dermal, and pulmonary), distribution, metabolism, and excretion were considered, along with reference to behaviors and other factors associated with child-specific exposures. The available information was summarized in a timeline of maturation for biological processes. It indicates variability in the duration and timing of maturation for each biological function. Possible implications for understanding pediatric sensitivity to environmental chemicals are discussed in light of factors affecting exposure through development. Themes that emerge from the evidence are presented as hypothesis-generating conclusions. This approach may be useful for evaluating developmental trends of susceptibility, and for identifying time periods and/or chemical classes of particular concern and thus important to consider in risk assessment.
In this post hoc analysis of healthy premature infants, the pentavalent rotavirus vaccine was generally well-tolerated and substantially reduced rotavirus-attributable hospitalizations and emergency department visits compared with placebo. Overall, vaccine safety and efficacy seemed to be generally comparable to the results in the REST study population as a whole. These results support vaccinating healthy premature infants on the same schedule as term infants.
The strategy of decreasing the morbidity and mortality associated with rotavirus gastroenteritis through vaccination is supported by studies demonstrating that wild-type rotavirus infection protects against subsequent rotavirus disease. Primary infection with wild-type rotavirus typically induces homotypic immunity. Vaccination of infants with a multivalent vaccine directed against prevalent rotavirus serotypes is the strategy most likely to provide the broadest degree of protection against rotavirus gastroenteritis. The pentavalent human-bovine reassortant rotavirus vaccine (HBRV) is directed against each of the most prevalent rotavirus serotypes, including G1, G2, G3, G4, and P1. The safety, immunogenicity, and efficacy of different reassortant compositions and formulations of the HBRV have been evaluated in clinical trials. An HBRV dose of > or =8 x 10(6) plaque-forming units has demonstrated 68.8%-76.6% efficacy against any rotavirus gastroenteritis, regardless of severity, and approximatel 100% efficacy against severe rotavirus gastroenteritis for the first rotavirus infection season after vaccination. The HBRV has been generally well tolerated, with no increase in the incidence of fever, vomiting, diarrhea, or behavioral changes among vaccine recipients, compared with placebo recipients, during the 14- and 42-day periods after administration of any dose. Shedding of vaccine strains in feces is uncommon. A large-scale trial is under way to evaluate the efficacy and safety of the manufacturing-scale formulation of pentavalent HBRV.
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