Antibodies to tetanus, diphtheria and pertussis among healthy adults vaccinated according to the French vaccination recommendations.

In this sero-epidemiological study, we investigated humoral immunity to three vaccine-preventable diseases--tetanus, diphtheria and pertussis--among 331 adults (aged 18-60 years) attending vaccination centres for travellers and who had been vaccinated according to national recommendations in France. Serological results showed that the percentage of subjects with antibodies to diphtheria and tetanus decreases with age. Results also confirmed surveillance data on vaccination in France, with 7.6% of the study population (13.4% of those aged 18-29 years) having recently acquired a pertussis infection. These results confirm the importance of following French recommendations for regular boosters for tetanus and diphtheria among adults. They also indicate the need for better implementation of the current recommendations for pertussis-vaccine boosters in adults.

Antibiotics for nasopharyngitis are associated with a lower risk of office-based physician visit for acute otitis media within 14 days for 3- to 6-year-old children.

OBJECTIVES: This study was designed to analyse factors potentially influencing children's return visits to physicians for symptoms of acute otitis media (AOM) within 14 days after being diagnosed with nasopharyngitis (NP), and the impact of recent antibiotic use. DESIGN: A controlled population-based pharmaco-epidemiological trial in 3- to 6-year-old children conducted from January to May 2000. SETTING: Three different geographical regions in France. PARTICIPANTS: Among 2507 eligible children, 2456 could be analysed and 505 children had 634 office-based physician visits (OBPV) for NP symptoms. INTERVENTIONS: The statistical associations between antibiotics prescribed for NP and an OBPV for AOM within 14 days in a population-based study were analysed along with risk factors of AOM. MAIN OUTCOMES MEASURE: Clinical events and antibiotic use. RESULTS: During the 2 weeks following physician-diagnosed NP, antibiotic use, especially a beta-lactam, significantly decreased the risk of OBPV for AOM in children (odds ratio=0.2; 95% confidence interval=0.09-0.7; P=0.002). CONCLUSION: Antibiotics prescribed to children for NP seem to protect during the following 2 weeks against the risk of OBPV for AOM. It remains to be determined whether a subgroup at high risk of developing AOM after a viral infection exists and what might be the best strategy to adopt for NP in a national programme of optimal antibiotic use.

Experience using MedDRA for global events coding in HIV clinical trials.

OBJECTIVES: To assess the feasibility of coding with MedDRA, the Medical Dictionary for Regulatory Activities, not only serious adverse events required for notification but also all other events usually reported in HIV clinical trials. To develop an approach for MedDRA implementation within an institutional research unit that contributes to an efficient, concise and reproducible event coding. To evaluate the impact of the maintenance and the versioning of this new medical terminology. METHODS: MedDRA versions 3.0 and 5.0 were used for coding hundreds of events reported through two HIV clinical trials. The implementation of MedDRA consisted in the setup of a training program, guidelines to clinical investigators, coding rules and medical validation process. MedDRA version 6.1 was applied to the coding made with the MedDRA version 5.0 in order to identify the assignments affected by the new version and to determine the impact of versioning. RESULTS: Coding with MedDRA all types of events in HIV clinical trials was feasible even though coders experienced some difficulties due mainly to the lack of precision in the investigator verbatim and the high specificity and sensitivity of MedDRA. The addition of appropriate tools to support the use of MedDRA improved significantly the coding of all types of events in HIV clinical trials. The impact of MedDRA versioning was limited and did not result in significant issues. The global implementation process of MedDRA required important resources in terms of qualified personnel, organisation and maintenance. CONCLUSIONS: Guidelines for investigators, coding rules and medical validation appeared to be mandatory for a successful implementation of MedDRA. The use of MedDRA, with the addition of the mentioned support tools, should ensure coding consistency and facilitate the clinical and tolerance analyses and meta-analyses in clinical trials.