Vaccine
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Randomized Controlled Trial Multicenter Study
Influenza A (H1N1) 2009 two-dose immunization of US children: an observer-blinded, randomized, placebo-controlled trial.
The goal of this pediatric clinical trial was to assess the safety and immunogenicity of two different doses of a monovalent inactivated pandemic (H1N1) 2009 vaccine in US children aged 6 months to 9 years of age. Randomized, observer-blinded, US multicenter phase 2 study assessing 2 doses of vaccine given 21 days apart in 474 children aged 6-35 months or 3-9 years. Children in each age group were randomly assigned to receive either a pandemic (H1N1) 2009 vaccine containing 7.5 or 15 μg of hemagglutinin (HA) or placebo in a 4:4:1 ratio. ⋯ A second dose of A H1N1 vaccine further increased HI antibody responses with seroprotection and seroconversion rates reaching 90-99% in both age groups. Interestingly, the pandemic (H1N1) 2009 vaccine formulations elicited similar rates of solicited and unsolicited injection site and systemic reactions as the placebo. The data therefore demonstrate the high level immunogenicity in infants and children of an (H1N1) 2009 influenza vaccine displaying a safety and reactogenicity profile similar to placebo.
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Parents' attitudes toward MMR vaccine and measles, mumps and rubella infections relate to their child's MMR status, therefore improving these attitudes is central to improving current suboptimal MMR uptake. However, no study has yet combined evidence-based, comprehensive and psychometrically validated assessment of these attitudes with reliable objective MMR status data, in order to identify through multivariate analyses the strongest attitudinal predictors of MMR uptake for interventions to target. The present study fills this lacuna by developing and testing a robust evidence-based MMR attitudes measurement instrument. ⋯ The measurement instrument is robust on multiple validity and reliability dimensions, and is appropriate for use in research and practice as a tool for designing and evaluating interventions. Parents appear to act in line with their attitudes toward MMR vaccine, though attitudes toward measles infection bore little relation to MMR uptake. This study indicates populations and attitudes to be prioritized in MMR uptake improvement interventions.
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Comparative Study
Evaluation of the reliability, validity and practicality of 3 measures of acute pain in infants undergoing immunization injections.
There is a need to identify a primary measure of infant pain that can be used to assess pain in infants undergoing vaccine injections in order to facilitate vaccine outcomes research. The aim of the present study was to determine the reliability, validity and practicality of 3 measures of acute pain in infants; the Modified Behavioural Pain Scale (MBPS), Neonatal Infant Pain Scale (NIPS), and Face Legs Activity Cry Consolability Scale (FLACC). Five raters rated pain from videotapes in 120 infants aged 2-6 months undergoing vaccine injections that participated in a randomized controlled trial designed to compare pain responses between two vaccines, DPTaP-Hib vaccine and PCV vaccine. ⋯ All measures demonstrated a significant difference in pain scores between the more painful (PCV) and less painful (DPTaP-Hib) vaccine for scores obtained after a single viewing. The majority of raters (4 out of 5) preferred the MBPS. Together, these results provide preliminary support for the MBPS as the primary outcome of pain during vaccine injections in infants.
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The aim of the study was to investigate factors involved in vaccination acceptance among healthcare workers (HCWs) and adverse reactions rates associated with pandemic influenza vaccination. The study was carried out in the major teaching hospital of Sicily from November 2009 to February 2010 on 2267 HCWs. A total of 407 (18%) HCWs were vaccinated against the 2009 pandemic influenza A (H1N1). ⋯ Twelve (3.9%) out of 302 HCWs stated they experienced influenza-like illness episodes during the follow-up period. The use of an adjuvanted vaccine against pandemic influenza A (H1N1) appears to be an effective and safe preventive strategy, showing a prevalence of both local and systemic adverse reactions not very different from that seen after vaccination with non-adjuvanted seasonal influenza vaccine. Despite this finding, vaccination coverage among HCWs remains very low, suggesting the need to implement educational campaigns directed to groups with lower coverage rates.
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Our study reviews the spontaneous reports of adverse events following immunisation submitted to the Danish Medicines Agency during the 2009-2010 influenza A/H1N1v season. During the study period (4 November 2009-31 March 2010), 607 reports comprising 1885 adverse events were reported among 339,507 influenza A/H1N1v vaccinated individuals (reporting rate, 179 per 100,000 vaccinated). ⋯ In conclusion, we did not observe any strong signals of any unknown or serious adverse events associated with influenza A/H1N1v vaccination in Denmark. Our experience also demonstrates the well-known limitations of spontaneous reports with respect to evaluation of a casual relationship and highlights the importance for a timely availability of background events rates and the need for new approaches to study late adverse effects following immunisation.