Objectives: To investigate whether meningococcal C conjugate vaccine (MCCV) caused relapse in children with steroid-responsive nephrotic syndrome. Design: A population-based study was conducted using an active surveillance system, developed to assess adverse events following vaccination, which linked hospital record information on relapses of nephrotic syndrome to community child health population MCCV data. An ecological study looking at hospital admissions for nephrotic syndrome in different age cohorts of children before and after the MCCV introductory campaign was also carried out. Settings: South East England, and England and Wales. Patients: 52 children having 162 relapses of nephrotic syndrome. Also, all hospital admissions of children aged 2-18 years with steroid-responsive nephrotic syndrome in England and Wales between 1995 and 2003, relating admissions to when MCCV was introduced in specific age cohorts. Main outcome measures and analysis method: Self-controlled case series analysis looking for increased risk of relapse following MCCV and changes in admission rates for nephrotic syndrome (incidence ratio) following the introduction of MCCV to different age cohorts of children. Results: There was no increased risk of relapse following MCCV in the self-control case series, where a relative incidence of 0.95 (95% confidence interval (CI) 0.61-1.47) was found in the 6-month postvaccination period, or in the ecological study, which gave an incidence rate ratio of 1.05 (95% CI 0.95 to 1.15) for the quarter when MCCV was introduced and the following two quarters. Conclusions: We found no association between MCCV and nephrotic syndrome, which is therefore not a contraindication to meningococcal vaccination.T here have been a few anecdotal reports implicating immunisation as a trigger for relapse of nephrotic syndrome in childhood.1 In 2003, a specific increased risk for relapse was suggested after administration of meningococcal C conjugate vaccine (MCCV), based on a study of children with steroid-sensitive nephrotic syndrome attending a tertiary children's hospital.2 A relative incidence of 1.84 (95% confidence interval (CI) 1.27 to 2.65) was reported for relapses in the 6-month post-vaccination period compared with 12 months pre-vaccination. While this study raised the possibility of an increased risk, it could not test the hypothesis because the assessed population contained the nine cases whose original relapses, apparently following MCCV administration, were the basis of the possible association. We have now independently tested the hypothesis.Confirmation or refutation of an effect seemed particularly important, as following the Lancet publication, 2 the UK Committee on Safety of Medicines stated: ''In children with steroid-responsive nephrotic syndrome, Meningococcal C vaccination has been shown to be associated with a relapse of the condition within 6 months post-immunisation. The benefit of vaccination should be carefully weighed against the risk of relapse of nephrotic syndrome in any patient with a...