Dataset Information

Background rates of disease in Latin American children from a rotavirus vaccine study.

ABSTRACT: Knowledge of background rates of adverse events is crucial to assess vaccine safety concerns. We used data from a rotavirus vaccine study (Ruiz-Palacios et al., NEJM, 2006) including 63,225 infants from 11 Latin American countries to investigate reporting rates of serious adverse events (SAEs) among these infants, and describe rates by country, gender, age, and season.For this randomized, double-blind, placebo-controlled, phase 3 trial, investigators from Argentina, Brazil, Chile, Colombia, Dominican Republic, Honduras, Mexico, Nicaragua, Panama, Peru, and Venezuela recruited 6-to-13-week-old healthy infants. The infants received 2 oral doses of vaccine or placebo. The study population was followed 100 d for the assessment of adverse events. SAEs were captured by an active surveillance system.Strong differences in event rates could be observed between countries (min. 48.1/10,000 person-years in Dominican Republic/Peru; max. 296.2/10,000 person-years in Brazil) and between genders: gastroenteritis, pneumonia, bronchiolitis and bronchitis occurred significantly more frequently in males. In addition, infections and infestations, and most disorders, including immune system and cardiac disorders, were more frequent at earlier ages. Finally, looking at seasonality we noted higher rates of SAEs in the second half of the year in all countries except Mexico.Significant differences in reporting rates of SAEs between countries, gender and calendar months illustrate the importance of knowing the local epidemiology when interpreting SAEs. Data from clinical trials can be used to better understand background rates of diseases that may be perceived as potential adverse events following immunization.

SUBMITTER: Baay M

PROVIDER: S-EPMC5557225 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Background rates of disease in Latin American children from a rotavirus vaccine study.

Baay Marc M Bollaerts Kaatje K Struchiner Claudio C Verstraeten Thomas T

Human vaccines & immunotherapeutics 20170425 8

<h4>Background</h4>Knowledge of background rates of adverse events is crucial to assess vaccine safety concerns. We used data from a rotavirus vaccine study (Ruiz-Palacios et al., NEJM, 2006) including 63,225 infants from 11 Latin American countries to investigate reporting rates of serious adverse events (SAEs) among these infants, and describe rates by country, gender, age, and season.<h4>Methods</h4>For this randomized, double-blind, placebo-controlled, phase 3 trial, investigators from Argen ...[more]

PMID: 28441094

Similar Datasets

Project description:BackgroundRadiology is a useful tool for diagnosis and intervention in medical practice, and all the components within the teaching-learning process of this subject during undergraduate studies influence successful knowledge application.ObjectiveThis study aimed to describe the level of knowledge in radiology of students in the last two years of medical school and curricular characteristics of their courses in seven Latin American countries.MethodsA multicenter cross-sectional study was carried out on medical students of 7 Latin American countries (Bolivia, Brazil, Colombia, Ecuador, Mexico, Paraguay, and Peru) in their final two years of medical school, using an online questionnaire validated by experts and adapted for each country that assessed knowledge and curricular characteristics in radiology subject. Scores were assigned according to the number of correct answers for the knowledge test. The T-test, and regression analysis with one-way ANOVA were used to search for relationships between the level of knowledge and other variables.ResultsA total of 1514 medical students participated in this study. All countries had similar participation (n > 200); most participants were women 57.8%. The country with the highest knowledge score was Brazil. Male, sixth year (internship) and from public universities students had higher knowledge score (n < 0.05). Participants, who considered radiology more important, and who reported higher compliance with teaching staff with the proposed syllabus, and programmed classes, obtained better scores (n < 0.05).ConclusionsLatin American medical students included in this study have a regular overall level of knowledge of Radiology, apparently influenced by curricular differences such as class and academic program compliance. Efforts to better understand and improve academic training are indispensable.LimitationsThe study was subject to selection bias determined by non-probability convenience sampling. The questionnaire assessed only theoretical knowledge and the evaluation system was designed by the investigators.

Dataset Information

Background rates of disease in Latin American children from a rotavirus vaccine study.

Publications

Background rates of disease in Latin American children from a rotavirus vaccine study.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets