Sudden unexpected deaths and vaccinations during the first two years of life in Italy: a case series study

Autor: Giuseppe, Traversa, Stefania Spila Alegiani, Clara, Bianchi, Marta Ciofi degli Atti, Luisa, Frova, Marco, Massari, Roberto, Raschetti, Stefania, Salmaso, Gianpaolo Scalia Tomba, the HERA STUDY GROUP: Bruno Caffari, Lidia, Fagiolo, Marina, Maggini, Francesca Menniti Ippolito, Lucia Pastore Celentano, Paola, Ruggeri, Marilena, Pappagallo, Carmela, Santuccio, Valeria, Severi, Cristina, Montomoli, Antonio, Cassone, Roberta, Crialesi, Paolo, D’Argenio, Filippo, Drago, Federico, Giovanni, Donato, Greco, Luigi, Macchi, Mara, Giacomazzi, Angela, Moiraghi, Patrizia, Popoli, Pasqualino, Rossi, Loredana, Vellucci, Carla, Granchelli, Felice, Vitello, Gabriella, Cauzillo, Salvatore, Lopresti, Renato, Pizzuti, Mariarosaria, D’Amico, Elvira, Lorenzo, Luisella, Grandori, Clara, Zuch, Angela, Spinelli, Roberto, Gasparini, Anna, Pavan, Carlo, Zocchetti, Gualtiero, Grilli, Lina, D’Alò, Vittorio De Micheli, Lopalco, PIETRO LUIGI, Anna Maria Vecchi, Rita, Masala, Patrizia, Miceli, Anna, Tosti, Francesco La Rosa, Carlo, Romagnoli, Emanuela, Balocchini, Grazia, Graziani, Serenella, Acciai, Luigi, Sudano, Patrizia, Vittori, Federica, Michieletto
Jazyk: angličtina
Rok vydání: 2011
Předmět:
Pediatrics
Non-Clinical Medicine
Epidemiology
lcsh:Medicine
Sudden cardiac death
Death
Sudden
Sudden deaths
vaccination
Italy
lcsh:Science
Pediatric Epidemiology
Multidisciplinary
Child and Adolescent Health Policy
Data Collection
Age Factors
Child Health
Immunizations
Vaccination
Data Interpretation
Statistical
Observational Studies
Medicine
Public Health
Research Article
Risk
medicine.medical_specialty
Drugs and Devices
Clinical Research Design
Sudden death
Population Metrics
Adverse Reactions
Death Rate
medicine
Humans
Biology
Health Care Policy
Population Biology
business.industry
Pharmacoepidemiology
lcsh:R
Infant
Newborn
Immunity
Infant
Health Risk Analysis
Sudden infant death syndrome
medicine.disease
Confounding effect
Settore MAT/06 - Probabilita' e Statistica Matematica
Increased risk
Immunization
lcsh:Q
Clinical Immunology
business
Case series
Zdroj: PLoS ONE
PLoS ONE, Vol 6, Iss 1, p e16363 (2011)
Popis: Background The signal of an association between vaccination in the second year of life with a hexavalent vaccine and sudden unexpected deaths (SUD) in the two days following vaccination was reported in Germany in 2003. A study to establish whether the immunisation with hexavalent vaccines increased the short term risk of SUD in infants was conducted in Italy. Methodology/Principal Findings The reference population comprises around 3 million infants vaccinated in Italy in the study period 1999–2004 (1.5 million received hexavalent vaccines). Events of SUD in infants aged 1–23 months were identified through the death certificates. Vaccination history was retrieved from immunisation registries. Association between immunisation and death was assessed adopting a case series design focusing on the risk periods 0–1, 0–7, and 0–14 days after immunisation. Among the 604 infants who died of SUD, 244 (40%) had received at least one vaccination. Four deaths occurred within two days from vaccination with the hexavalent vaccines (RR = 1.5; 95% CI 0.6 to 4.2). The RRs for the risk periods 0–7 and 0–14 were 2.0 (95% CI 1.2 to 3.5) and 1.5 (95% CI 0.9 to 2.4). The increased risk was limited to the first dose (RR = 2.2; 95% CI 1.1 to 4.4), whereas no increase was observed for the second and third doses combined. Conclusions The RRs of SUD for any vaccines and any risk periods, even when greater than 1, were almost an order of magnitude lower than the estimates in Germany. The limited increase in RRs found in Italy appears confined to the first dose and may be partly explained by a residual uncontrolled confounding effect of age.
Databáze: OpenAIRE
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