Vaccine
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Randomized Controlled Trial Multicenter Study
Co-administration of human papillomavirus-16/18 AS04-adjuvanted vaccine with hepatitis B vaccine: randomized study in healthy girls.
To evaluate co-administration of GlaxoSmithKline Biologicals' human papillomavirus-16/18 AS04-adjuvanted vaccine (HPV) and hepatitis B vaccine (HepB). ⋯ ClinicalTrials.gov registration number NCT00652938.
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The cost-effectiveness of introducing infant rotavirus vaccination in Armenia in 2012 using Rotarix(R) was evaluated using a multiple birth cohort model. The model considered the cost and health implications of hospitalisations, primary health care consultations and episodes not leading to medical care in children under five years old. Rotavirus vaccination is expected to cost the Ministry of Health $220,000 in 2012, rising to $830,000 in 2016 following termination of GAVI co-financing, then declining to $260,000 in 2025 due to vaccine price maturity. ⋯ The cost per disability-adjusted life year (DALY) saved is estimated to be about $650 from the perspective of the Ministry of Health, $850 including costs accrued to both the Ministry and to GAVI, $820 from a societal perspective excluding indirect costs and $44 from a societal perspective including indirect costs. Since the gross domestic product per capita of Armenia in 2008 was $3800, rotavirus vaccination is likely to be regarded as "very cost-effective" from a WHO standpoint. Vaccination may still be "very cost-effective" if less favourable assumptions are used regarding vaccine price and disease incidence, as long as DALYs are not age-weighted.
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Randomized Controlled Trial Multicenter Study Comparative Study
A phase I randomized, double-blind, controlled trial of 2009 influenza A (H1N1) inactivated monovalent vaccines with different adjuvant systems.
We conducted a phase I, multicenter, randomized, double-blind, placebo-controlled, multi-arm (10) parallel study involving healthy adults to evaluate the safety and immunogenicity of influenza A (H1N1) 2009 non-adjuvanted and adjuvanted candidate vaccines. Subjects received two intramuscular injections of one of the candidate vaccines administered 21 days apart. Antibody responses were measured by means of hemagglutination-inhibition assay before and 21 days after each vaccination. The three co-primary immunogenicity end points were the proportion of seroprotection >70%, seroconversion >40%, and the factor increase in the geometric mean titer >2.5. ⋯ Adjuvant systems can be safely used in influenza vaccines, including the adjuvant monophosphoryl lipid A (MPL) derived from Bordetella pertussis with squalene and aluminum hydroxide, MPL with aluminum hydroxide, and squalene and aluminum hydroxide.
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After over two decades of immense efforts, the global polio eradication initiative may be approaching its final phase. With leadership from WHO, great efforts of national programs and support from its collaborators, combined with the recent use of mono and bivalent oral polio vaccines, success may be at hand. For a "safe landing" of this global program, it is important once more to recall the key role of routine vaccination as the foundation on which mass vaccination campaigns can be successful. ⋯ Considering the large number of subclinical poliovirus infections, failing to reduce the number of unvaccinated persons per km(2) could severely impact the final stage of eradication. Here the authors, from their personal perspectives, discuss how the current program will be viewed from 2012 onwards. The authors will highlight the epidemiological importance of circulating vaccine-derived poliovirus, the problem of biosecurity as well as the use of inactivated polio vaccine and how each of these may affect the post eradication era and how research into each of these must continue to ensure success.
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Multicenter Study
Vaccine effectiveness for laboratory-confirmed influenza in children 6-59 months of age, 2005-2007.
To estimate the effectiveness of influenza vaccine against medical care visits for laboratory-confirmed influenza in young children we conducted a matched case-control study in children with acute respiratory illness or fever from 2005-2007. Influenza vaccine effectiveness (VE) was calculated using cases with laboratory-confirmed influenza and controls who tested negative for influenza. The effectiveness of influenza vaccine in fully vaccinated children 6-59 months of age was 56% (95% CI: 25%-74%); a significant VE was not found for partial vaccination.