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Influenza is a major cause of illness. We have assessed the safety, efficacy, and effectiveness of CAIV-T vaccine. A two year, multicenter, double-blind, placebo-controlled, efficacy field trial in pre-school aged children was conducted; 1602 enrolled in Year One and 1358 (85%) returned in Year Two. In both study years combined, the overall vaccine efficacy against culture-confirmed influenza was...
Live attenuated cold-adapted influenza vaccines (CAIVs) have been developed over the past two decades by taking advantage of the segmented RNA genome of influenza and creating attenuated reassortants containing contemporary hemagglutinin (HA) and neuraminidase (NA) genes. These vaccines have been shown to be easily administered, safe and immunogenic in adults and children.Recent trials of a trivalent...
The use of vaccines for the prophylaxis of influenza in children is limited. This is despite high annual rates of influenza in children and despite the complications caused by influenza in children with chronic respiratory illnesses. The disease burden of influenza on infants and young children is reviewed and the potential of recommended influenza vaccination in healthy children, to reduce the direct...
Health and economic burden of recurrent respiratory tract infections (RTIs) in early childhood is considerable. A systematic review of licensed influenza and pneumococcal vaccines showed substantial efficacy in children, but the health-economic impact of such vaccines among pre-school children with recurrent RTIs is unknown. We therefore, designed a double-blind randomized controlled trial to determine...
To inform the development of a national influenza immunisation programme and the potential role of antiviral drugs in young children, we studied 613 children aged 71 months or younger who attended Leicester Childrens’ Hospital during winter 2001–2002. During periods of respiratory syncytial virus (RSV), influenza, and human metapneumovirus activity, an estimated 12.2% (95% CI: 11.4–13.1), 7.1% (6...
This paper reports the data concerning the net economic cost savings attributable to influenza vaccination in healthy children aged 2–5 years, and may be useful when deciding the best recommendations for the use of influenza vaccine in pediatrics.A total of 303 previously unprimed healthy children aged 2–5 years (163 males; mean age±S.D.: 3.22±2.43 years) were prospectively, blindly randomised in...
We evaluated influenza vaccination coverage in children with chronic disease at high risk of influenza complications, and the need for methods to increase parents’ and pediatricians’ knowledge of influenza and its prevention. The 5286 children aged less than 14 years attending our Emergency Department on Wednesdays and Sundays between 1 January and 30 April 2003 included 274 (5.2%) high-risk patients...
Decisions regarding the introduction of influenza immunization in healthy children require an accurate evaluation of influenza disease burden not only in the inpatient but also in the outpatient setting. We prospectively examined the impact of virologically confirmed influenza in 1462 outpatient children (≥6 months to <14 years) and their families, during two consecutive influenza seasons. Influenza...
To evaluate the effectiveness of a virosomal subunit influenza vaccine in preventing influenza-related illnesses and its social and economic consequences in children aged 3–14 years, a prospective cohort study was carried out during the 2004–2005 influenza season in 11 private pediatric clinics in the Barcelona metropolitan area. One dose of a virosomal subunit inactivated influenza vaccine (Inflexal...
Vaccinating children at day-care may be a cost-effective approach for improving influenza immunization rates in this high-risk group. This study uses influenza attack-rate data from a randomized, blinded, placebo-controlled clinical trial of live-attenuated influenza vaccine, trivalent in day-care centres from two consecutive influenza seasons, one with a moderate attack rate (H1N1 dominant) and one...
Children previously unvaccinated against influenza are recommended to receive two doses of trivalent inactivated influenza vaccine (TIV). This study assessed the age limit for a second dose of TIV in previously unvaccinated children. Two hundred and twenty-four children were immunized with TIV (Influsplit SSW™/Fluarix™; GlaxoSmithKline Biologicals). Subjects aged 6–9 years (n=110) received two doses...
The US Advisory Committee on Immunization Practices (ACIP) recently expanded the influenza vaccine recommendation to include children 24–59 months of age. In a large head-to-head randomized controlled trial, live attenuated influenza vaccine, trivalent (LAIV) demonstrated a 54% relative reduction in culture-confirmed influenza illness compared with trivalent inactivated influenza vaccine (TIV) among...
The burden of influenza is well known in the elderly and at-risk patients, but also in children. Especially in those under 5 years old, influenza may cause severe morbidity and mortality. Influenza infections and complications can be reduced by vaccination. In a randomized, endpoint-blinded, parallel group trial the immunogenicity and safety was studied of two trivalent inactivated surface antigen...
In order to evaluate whether the virosomal adjuvanted influenza vaccine that has been shown to have the lowest egg protein content (Inflexal V, Berna Biotech) could be administered to children with even severe egg allergy without any risk of allergic reactions, we used epicutaneous skin testing with the undiluted vaccine in 88 asthmatic children (44 with and 44 without egg allergy), none of whom had...
The effectiveness of influenza vaccine over multiple influenza seasons in children less than 5 years of age has not been well studied. This is especially important to assess because of the recent recommendation for routine influenza vaccination in childhood.We conducted a matched case–control study to assess the vaccine effectiveness of Trivalent Inactivated Influenza Vaccine (TIV) against laboratory-confirmed,...
After priming with two intramuscular doses of MF59 ® -adjuvanted (Sub/MF59) or split influenza vaccines during the 2006/07 season, 89 healthy children received a third booster dose of the respective vaccine (2007/08 Northern Hemisphere formulation) approximately 1 year later, and were followed up for 6 months post-third injection. Immunogenicity was evaluated on 81 of them by a hemagglutination...
Recombinant baculovirus-expressed hemagglutinin (rHA [FluBlok ® ]) influenza vaccine is unique in avoiding production in eggs and its rapid production capability.Compare the safety and immunogenicity of trivalent FluBlok to egg-grown trivalent influenza vaccine (TIV) in children.Healthy children were randomized to receive two doses of study vaccines. TIV (7.5μg HA/antigen), FluBlok-22.5 (22...
This study determined direct medical costs for influenza-associated hospitalizations and emergency department (ED) visits. For 3 influenza seasons, children <5 years of age with laboratory-confirmed influenza were identified through population-based surveillance. The mean direct cost per hospitalized child was $5402, with annual cost burden estimated at $44 to $163 million. Factors associated with...
This study evaluated the immunogenicity of a double dose of the seasonal virosomal-adjuvanted influenza vaccine (Inflexal V, Crucell, The Netherlands) in 65 previously unvaccinated children aged less than 3 years: 43 received double doses (two doses of 0.50mL 4 weeks apart) and 22 standard doses (two doses of 0.25mL 4 weeks apart). Both treatments evoked a response that satisfied the EMEA criteria...
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