| Author | Buettcher, Michael | |
| Author | Heininger, Ulrich | |
| Author | Braun, Miles | |
| Author | Bonhoeffer, Jan | |
| Author | Halperin, Scott | |
| Author | Heijbel, Harald | |
| Author | Martins, Reinaldo de Menezes | |
| Author | Bondt, Patricia Vermeer-de | |
| Access date | 2024-06-13T12:49:24Z | |
| Available date | 2024-06-13T12:49:24Z | |
| Document date | 2007 | |
| Citation | BUETTCHER, Michael et al. Hypotonic-hyporesponsive episode (HHE) as an adverse event following immunization in early childhood: Case definition and guidelines for data collection, analysis, and presentation. Vaccine, v. 25, n. 31, p. 5875-5881, Aug. 2007. | en_US |
| ISSN | 0264-410X | en_US |
| URI | https://www.arca.fiocruz.br/handle/icict/64478 | |
| Language | eng | en_US |
| Publisher | Elsevier | en_US |
| Rights | open access | en_US |
| Title | Hypotonic-hyporesponsive episode (HHE) as an adverse event following immunization in early childhood: Case definition and guidelines for data collection, analysis, and presentation | en_US |
| Type | Article | en_US |
| DOI | 10.1016/j.vaccine.2007.04.061 | |
| Abstract | To increase comparability of vaccine clinical safety data and to improve the quality of reported data by applying the same criteria, the Hypotonic-hyporesponsive episode (HHE) Working Group has developed a case definition and guidelines for HHE applicable in study settings with different availability of resources, in health care settings that differ by availability of and access to health care, and in different geographic regions. The definition and guidelines were developed through group consensus and are grounded in both expert opinion and a systematic literature review related to the assessment of HHE as an adverse event following immunization (AEFI) and to the diagnosis of HHE in humans. The only published structured work put into the development of a case definition for HHE resulted from a U.S. public health service workshop on HHE after pertussis immunization [1]. This definition has served as the basis for consensus formation within the working group. | en_US |
| Affilliation | University Children’s Hospital. Basel, Switzerland. | en_US |
| Affilliation | University Children’s Hospital. Basel, Switzerland. | en_US |
| Affilliation | Food and Drug Administration. Rockville, MD, USA. | en_US |
| Affilliation | University Children’s Hospital. Basel, Switzerland. | en_US |
| Affilliation | Dalhousie University. Halifax, Nova Scotia, Canada. | en_US |
| Affilliation | Swedish Institute of Infectious Disease Control. Lund, Sweden. | en_US |
| Affilliation | Fundação Oswaldo Cruz. Instituto de Tecnologia em Imunobiológicos (Bio-Manguinhos). Rio de Janeiro, RJ, Brasil. | en_US |
| Affilliation | National Institute for Public Health and Environment. Bilthoven, The Netherlands. | en_US |
| Subject | Hypotonic-hyporesponsive episode (HHE) | en_US |
| Subject | Adverse event | en_US |
| Subject | Immunization | en_US |
| Subject | Guidelines | en_US |
| Subject | Case definition | en_US |
