Effectiveness and safety of the A-H1N1 vaccine in children: A hospital-based case - Control study

Francesca Menniti-Ippolito, Roberto Da Cas, Luciano Sagliocca, Giuseppe Traversa, Fernanda Ferrazin, Carmela Santuccio, Loriana Tartaglia, Francesco Trotta, Pasquale Di Pietro, Salvatore Renna, Rossella Rossi, Bianca Domenichini, Stefania Gamba, Francesco Trovato, Pier Angelo Tovo, Manuela Bianciotto, Carmelina Calitri, Clara Gabiano, Irene Raffaldi, Antonio UrbinoLiviana Da Dalt, Valentina Favero, Laura Giordano, Maura Baraldi, Federica Bertuola, Eleonora Lorenzon, Francesca Parata, Giorgio Perilongo, Silvia Vendramin, Monica Frassineti, Anna Maria Calvani, Elena Chiappini, Maurizio De Martino, Claudia Fancelli, Francesco Mannelli, Rachele Mazzantini, Sara Sollai, Elisabetta Venturini, Nicola Pirozzi, Umberto Raucci, Antonino Reale, Nadia Mores, Giulia Bersani, Alessia De Nisco, Antonio Chiaretti, Riccardo Riccardi, Costantino Romagnoli, Vincenzo Tipo, Michele Dinardo, Teresa Pisapia, Annalisa Capuano, Elisabetta Parretta, Concita Rafaniello, Fortunata Fucà, Eleonora Di Rosa

Research output: Contribution to journalArticlepeer-review

Abstract

Objective: To verify whether vaccination against the A-H1N1 virus in the paediatric population was effective in preventing the occurrence of influenza-like illness (ILI) or was associated with adverse events of special interest. Design, setting and patients: A case-control analysis was performed as part of surveillance of children hospitalised through the emergency departments of eight paediatric hospitals/wards for ILI, neurological disorders, non-infectious mucocutaneous diseases and vasculitis, thrombocytopaenia and gastroduodenal lesions. Results: Among 736 children enrolled from November 2009 to August 2010, only 25 had been vaccinated with the pandemic vaccine. Out of 268 children admitted for a diagnosis compatible with the adverse events of special interest, six had received the A-H1N1 vaccine, although none of the adverse events occurred within the predefined risk windows. Only 35 children out of 244 admitted with a diagnosis of ILI underwent laboratory testing: 11 were positive and 24 negative for the A-H1N1 virus. None of the A-H1N1 positive children had received the pandemic vaccine. The OR of ILI associated with any influenza vaccination was 0.9 (95% CI 0.1 to 5.5). Conclusions: The study provides additional information on the benefit-risk profile of the pandemic vaccine. No sign of risk associated with the influenza A-H1N1 vaccine used in Italy was found, although several limitations were observed: in Italy, pandemic vaccination coverage was low, the epidemic was almost over by mid December 2009 and the A-H1N1 laboratory test was performed only during the epidemic phase (in

Original languageEnglish
Article numbere000167
JournalBMJ Open
Volume1
Issue number2
DOIs
Publication statusPublished - 2011

ASJC Scopus subject areas

  • Medicine(all)

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