Comparison of the safety and immunogenicity of concomitant and sequential administration of an adult formulation tetanus and diphtheria toxoids adsorbed combined with acellular pertussis (Tdap) vaccine and trivalent inactivated influenza vaccine in adults.

The annual contact for influenza vaccination provides an opportunity to ensure that adults have received other recommended vaccines such as Tdap. Healthy 19-64 year-olds were randomized to receive concomitant administration of Tdap and influenza vaccines or influenza vaccine followed (in 4-6 weeks by) Tdap. 720 participants were enrolled. No clinically relevant between-group differences were observed in the rates or severities of erythema, swelling, or pain at the Tdap injection site. Injection-site pain was the most commonly reported adverse event (66.6% concomitant administration group versus 60.8% sequential administration group); most pain was graded as mild and resolved by day 3. Seroprotection and seroresponse rates for all influenza strains were comparable between the two groups. For diphtheria and tetanus, seroprotection rates and post-vaccination GMTs were non-inferior in the concomitant administration group compared to the sequential administration group. A trend for lower antibody responses to pertussis antigens PT, FHA, and FIM was observed after concomitant administration and, for PRN, this difference failed the non-inferiority criteria. While there is a small diminution in antibody response to tetanus and pertussis antigens, concomitant administration of Tdap and influenza vaccine was well tolerated and immunogenic and may offer practical advantages including convenience, compliance, and cost-savings.

Risk factors for hospitalization and infection in Canadian Inuit infants over the first year of life--a pilot study.

OBJECTIVES: Inuit infants experience higher mortality and poorer health than other Canadian infants, and suffer disproportionately from bacterial and viral infections. A wide range of inter-related factors affect their health and susceptibility to infection. The objective of the study was to describe hospitalization and morbidity patterns in a cohort of 46 healthy Inuit infants from Iqaluit, Nunavut, over their first year of life. STUDY DESIGN: Risk factors for hospitalization and infections were assessed using multiple linear regression. RESULTS: Infants experienced an average of four respiratory tract infections (RTIs) annually, which accounted for half of the hospitalizations in the cohort. Some interesting trends were evident from the assessment of risk factors using multiple linear regression. Adoption was associated with adverse health effects in addition to those that would be expected due to lack of breast-freeding alone; among infants who were not breast-fed, adopted infants had three more RTIs per year than non-adopted infants. CONCLUSION: The results of this pilot study provide support for undertaking larger epidemiological studies in order to clarify the role of these risk factors, so that future preventive efforts can be informed and effective.

An overview of factors influencing the health of Canadian Inuit infants.

BACKGROUND: Inuit infants throughout the Arctic experience higher mortality and poorer health than their non-Inuit counterparts, and suffer disproportionately from bacterial and viral infections. STUDY DESIGN: This review examines the health status of these infants, with a focus on Canadian Inuit communities and reference to other circumpolar regions, as appropriate. It is based on a Medline search (1965 to present), special analyses of the 1996 Canadian Census and various national surveys, and selected government reports and documents. RESULTS: A wide range of inter-related factors affect the health of Inuit infants: their demographic, social, economic and physical environment, as well as personal health practices and the availability of high quality, culturally appropriate health services. Some of these factors may influence the susceptibility of Inuit infants to infection. Smoking is highly prevalent in Inuit communities, and its indisputable negative effects on health, including increased risk of respiratory tract infection in infants, represent an urgent public health challenge. CONCLUSION: Locally driven, focused and methodologically sound epidemiological research that addresses key gaps in knowledge could lead to more appropriate and effective preventive strategies to improve health in northern communities.

Safety and immunogenicity of a trivalent, inactivated, mammalian cell culture-derived influenza vaccine in healthy adults, seniors, and children.

We performed randomized, double-blind, controlled trials to assess the safety and immunogenicity of an inactivated, Madin Darby Canine Kidney (MDCK)-derived cell line produced influenza vaccine in healthy adults (19-50 years), children (3-12 years) and the elderly (> or =65 years). We studied three lots of cell culture-derived vaccine and one lot of licensed egg-derived vaccine in healthy adults (n=462), two lots of cell culture-derived vaccine and one lot of egg-derived vaccine in seniors (n=269), and one lot of each vaccine in children (n=209). Adverse events were collected during the first 3 days post-immunization; serum was collected before and 1 month after immunization. Rates of local and systemic adverse reactions were similar with both vaccines. An injection site adverse event rated at least moderate severity was reported by 21.9% of children who received the egg-derived vaccine and 25.0% of those who received the cell culture-derived vaccine. In healthy adults the proportions were 12.1 and 15.3%, respectively and 6.7 and 6.3%, respectively in seniors. Systemic events of at least moderate severity were 12.4 and 12.5% in children, 19.8 and 13.6% in healthy adults, and 14.1 and 9.7% in seniors; none of these differences were statistically significant. The antibody response against all three viruses was similar between the two vaccines. From 83 to 100% of children, healthy adults and seniors achieved hemagglutination inhibition titers in excess of 40 post-immunization. We conclude that the cell culture-derived vaccine was safe and immunogenic in children, healthy adults and seniors.