[Palivizumab immunoprophylaxis: use in clinical practice, safety and beneficial effects in France]. / Modalités d'utilisation, tolérance et bénéfice du palivizumab dans la prévention des infections à VRS en France : saison 2005-2006.

BACKGROUND: Infants treated have been followed for one year in order to assess conditions of use of palivizumab, safety, tolerability, and its impact on respiratory syncytial virus (RSV) hospitalisation rate. PATIENTS AND METHODS: Patients who received palivizumab during the epidemic season 2005-2006 were eligible. Follow-up was carried out 12 months after initiation of prophylaxis. RESULTS: Sixty-four neonatal level II and III centers, pulmonary and cardiology units enrolled 1420 children. Mean follow-up was 10.9+/-0.2 months, mean gestational age (GA) 30+/-4 weeks and mean age at the start of prophylaxis was 5 months. Median number of injections was 5 and mean time interval between 2 consecutive injections was 30+/-6 days. Treatment was prescribed in accordance with the marketing authorisation indications (MA) for 84% of patients. For preterm infants born before 35 SA and less than 6 months of age, 60% was born before 33 SA and without BDP. The global readmission rate (for more than 24h) for documented RSV infection during the period of protection by palivizumab was 2.7% (37 in 1371) for all treated children: respectively 2% [IC(95%)=1.3-3.2], 2.7% [IC(95%)=0.7-4.7] and 3.7% [IC(95%)=0.8-6.6] for preterm infants less than 6 months of age, preterm from 6 to 24 months of age and for children with congenital cardiopathy. Palivizumab safety and tolerability were good. CONCLUSION: Evaluation of palivizumab prophylaxis in clinical practice confirms the clinical characteristics of treated infants, outlines their evolution and confirms safety of treatment. MA were generally well observed and a registry could be usefull to track the impact of the treatment out of MA.

[Methodological aspects of economic evaluation in pediatrics: illustration by RSV infection prophylaxis in the French setting]. / Aspects méthodologiques de l'évaluation économique du médicament en pédiatrie : exemple de la prophylaxie de l'infection à VRS en France.

The methodological approach of the economic evaluation of drugs in pediatrics is illustrated by the case study of the prophylaxis for RSV infections using palivizumab in the French setting. The indications for the reimbursement of this treatment have been restricted to premature children with bronchopulmonary dysplasia (BPD) or hemodynamically significant congenital-heart disease. A model was developed primarily using the results of the pivotal clinical studies on palivizumab. Unit costs were estimated (2006 values) in both societal and payer's perspectives. An assumption was made and discussed on the benefits of the prophylaxis on mortality. Based on the different data available and the estimated costs and benefits, different cost-effectiveness ratios (CERs) were estimated from both the society's and payer's points of view. A discount rate of 3% was applied to benefit. The CER obtained in the most unfavorable case is considered acceptable for the innovative-medical technologies in the French-healthcare system. Some of the parameters used by the model will be illustrated from the EPIPAGE study data from 2 of the 9 regions involved in this study: this evaluation suggests that the children not having an RSV infection during their 1st year of life will continue to require significantly fewer hospitalizations in the following years. These additional evaluations also suggest that the model overestimates the costs of the treatment with regard to the true medical situation. This could be explained by the model not using the children's exact weight or the real number of injections because the children had been discharged from the maternity ward based on their date of birth and the epidemic period. In spite of these factors, RSV prophylaxis using palivizumab in premature children with BPD or hemodynamically significant congenital-heart disease can be considered cost-effective in France.

Immunogenicity and safety of a trivalent tetanus, low dose diphtheria, inactivated poliomyelitis booster compared with a standard tetanus, low dose diphtheria booster at six to nine years of age. Munich Vaccine Study Group.

OBJECTIVE: To compare the immunogenicity and safety of a trivalent tetanus-diphtheria (low toxoid content)-inactivated poliomyelitis vaccine, Td-IPV (Revaxis; Pasteur Merièux), with a tetanus-diphtheria (low toxoid content) vaccine, Td (Td-Impfstoff Mérieux; Pasteur Merièux), when administered as a booster to children age 6 to 9 years. METHODS: A group of 301 children were randomized and vaccinated with Td-IPV (n = 150) or Td (n = 151) in this open, controlled, multicenter trial. Serum specimens were obtained before and 28 days after vaccination. Safety was assessed for up to 28 days postvaccination by parental diary cards. Solicited local and systemic reactions were recorded for 7 days after vaccination. RESULTS: Seroprotection (enzyme-linked immunosorbent assay titer, > or =0.10 IU/ml) against tetanus and diphtheria was induced by either Td-IPV or Td in all subjects. Tetanus and diphtheria geometric mean titer were higher after Td (34.0 and 5.74 IU/ml) than after Td-IPV (15.9 and 4.38 IU/ml). All subjects boosted with Td-IPV were seroprotected against each type of poliovirus (neutralizing antibody titer, > or =5/dilution). The most frequently reported solicited local and systemic symptoms were pain triggered by movement of the arm (54% vs. 39.1%) and headache (17.3% vs. 7.3%), after Td-IPV and Td, respectively. All other events were similar between the two groups. Reactions were generally mild and all were temporary. CONCLUSIONS: A booster dose of Td-IPV induced in all children seroprotection against tetanus, diphtheria and poliomyelitis. The overall safety profile of the two vaccines was acceptable.