French survey about intradermal BCG SSI adverse events in children under 6 years of age

• Published in: Archives de pédiatrie : organe officiel de la Société française de pédiatrie 2007-01, Vol.14 (1), p.102
• Main Authors: Dommergues, M-A, de la Rocque, F, Dufour, V, Floret, D, Gaudelus, J, Guérin, N, Le Sage, F-V, Bocquet, A, Cohen, R
• Format: Article
• Language: fre
• Subjects: Adverse Drug Reaction Reporting Systems; BCG Vaccine - administration & dosage; BCG Vaccine - adverse effects; Child; Child, Preschool; France; Humans; Injections, Intradermal; Retrospective Studies; Surveys and Questionnaires
• ISSN: 0929-693X
• DOI: 10.1016/j.arcped.2006.10.005

During April 2006, 579 physicians took part in a survey about intradermal BCG SSI adverse events (AE) in children less than 6 years old, managed by InfoVac France. Since January 2006, 68% physicians (paediatricians: 73% and general practitioners [GP]: 60%) have vaccinated at least one child. The site of injection is mainly the extern side of the shoulder (72%), according to the recommendations. Systematic vaccination is continued by 54% GP and 26% paediatricians. Others indications are: admission in day care center (33%), admission in day care center associated with risk factors (24%), or only risks factors (8%). Half physicians observed AE and 6% of them reported them at pharmacovigilance centers or pharmaceutical company. AE were mainly inflammations or indurations over 1 cm (for 75% of physicians who observed AE), oozing (73%). Abscesses are notified by 54%, ulcers by 39%, lymphadenopathies over 1 cm by 20%, suppurative lymphadenopathies by 3% and keloid scares by 17% of them, several AE may coexist for some children. Our aim is to start a prospective follow-up of BCG-SSI vaccination and its AE; 58% physicians who answered this investigation agreed to participate.