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Query: UMLS:C0024530 (malaria)
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A survey on EPI, CDD, child morbidity, and mortality was conducted in 1988 in one province of northeastern Vietnam. Thirty out of 114 communes were randomly selected for the survey and the interviews were made by 60 students from the provincial nursing school, supervised by 10 teachers. It was found that 23 per cent of the children (n = 211) were fully vaccinated, while 54 per cent had partial coverage. Lack of information or ignorance were the main causes of vaccination failure. The adjusted yearly diarrhoeal rate was 1.6 per child under 5 years of age (n = 9.691). Infant mortality and under-five mortality rates were found to be 28 per thousand live births (95 per cent confidence interval: 21-35; n = 2.321) and 44 (36-52), respectively. High literacy among mothers, good breast-feeding practices, low mortality due to diarrhoea, malaria, and measles, and a well-functioning rural health care system were considered to be the main contributing factors to the low infant mortality. The results also point out the weaknesses in the existing reporting system and indicates the need for follow-up studies.
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PMID:Survey on immunization, diarrhoeal disease and mortality in Quang Ninh Province, Vietnam. 179 45

The impact of a combination of PHC intervention activities on child survival, growth, morbidity and mortality was assessed in three selected rural communities (Gomoa Fetteh, Gomoa Onyadze/Otsew Jukwa and Gomoa Mprumem) in the Central Region of Ghana from 1987 to 1990. EPI, provision of basic essential drugs and supplies for the treatment of common childhood diseases, treatment of the sick child, growth monitoring, health education, provision of antenatal services, family planning, training and supervision of Community Health Workers, disease surveillance and special studies were the major PHC strategies used to improve the health of the child and the pregnant woman in the three communities. These activities in their totality have had significant impact on morbidity and mortality in children under five and on maternal mortality in children under five and on maternal mortality over the study period 1987 to 1990. Although malaria, acute respiratory infections and diarrhoea diseases continue to be major causes of childhood morbidity, deaths due to these diseases have dramatically declined. Measles and other vaccine preventable diseases no longer contribute significantly to childhood morbidity and mortality. Infant and under five mortality have been reduced from 114.6/1000 and 155.6/1000 live births to 40.8/1000 and 61.2/1000 live births respectively. The crude birth rates however, remain almost the same over the five year period (43 to 48/1000 pop.) but crude death rates have declined (11 to 12.4/1000 pop.).(ABSTRACT TRUNCATED AT 250 WORDS)
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PMID:Impact of primary health care on child morbidity and mortality in rural Ghana: the Gomoa experience [corrected]. 762 99

A total of 249 persons living in the northwest part of Ecuador with a clinical diagnosis of malaria confirmed by thick blood films were treated with chloroquine and primaquine according to the therapeutical system in force in the National Service for Eradication of Malaria. New clinical assessment and thick blood film were applied after 4 days in P. falciparum (n = 120) cases and after 8 days in P. vivax (n = 129) cases; patients were questioned about the compliance or non-compliance with the treatment, and the reasons for their acting in either way were studied. EPI-INFO 6.04 and SPSS PC 7.0 packages served to process the information: "kind adjustment test" (bondad de ajuste) abd factorial analysis of correspondences were used. The patient who daily took his/her pills for the number of days indicated, at the established intervals and at the right time was defined as a patient complying with the drug therapy. For every 3 patients complying with treatment, there were 2 who did not; non-compliance was not significantly related to age, sex, educational level, ethnic group, urban or rural setting or level of income, but learning about seriousness of the infection did help to compliance with the therapy. The reasons for non-compliance were mainly associated with drugs (side effects/reluctancy to take drugs), with the fact of forgetting to take them and of "getting cured quickly". The profile of the patient who did not comply with treatment corresponded to male, teenager, mixed race, poor and rural setting.
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PMID:[The factors associated with noncompliance with antimalarial treatment in Ecuadorian patients]. 1110 99

The Children's Vaccine Initiative (CVI), which was founded after the World Summit for Children held in New York in September 1990, had three goals: 1) immunization of all children; 2) research to determine the feasibility of a single-dose multivalent vaccine; and 3) introduction of new vaccines for infectious diseases. UNICEF, UNDP, WHO, the World Bank, and the Rockefeller Foundation co-sponsored the CVI. The following has been achieved since 1990: 1) coverage with 6 EPI vaccines has risen above 80% in many countries; 2) the number of vaccines in the research pipeline has increased; 3) there is better planning of the global vaccine supply; and 4) governments of developing countries are assuming more responsibility for national immunization. The new strategic plan for CVI, which is the work of experts from government, industry, and international organization, establishes the following goals: 1) development of greater consensus on priorities regarding vaccine development and application; 2) definition of needs and strategies for action; 3) communication of the health and economic value of vaccines; and 4) mobilization of resources. Executive Secretary Dr. Lee and CVI coordinator Roy Widdus are responsible for the new role for CVI. 4 million children die annually from diseases preventable by existing vaccines; another 8 million die annually from diseases that could be prevented by new vaccines. Measles, hepatitis B, and Hib vaccines are underused. Vaccines against rotavirus diarrhea and pneumococcal pneumonia should be available soon, while research continues on vaccines against malaria and HIV.
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PMID:The Children's Vaccine Initiative. 1234 72

In October 2006, the World Health Organisation (WHO) convened a meeting of experts to discuss appropriate methods for evaluating the efficacy of malaria vaccines in pivotal phase III trials. The participants included regulatory, industry and donor representatives and clinical trialists, epidemiologists and statisticians from both developed and developing countries. The consultation also considered the regulatory requirements for registration of a malaria vaccine and public health issues that clinical development plans need to address before deployment of a malaria vaccine in developing countries. This report summarizes the discussions and conclusions reached during the course of the meeting. While the global public health burden of malaria is unquestionable there has been considerable variation in the ways in which a case of clinical disease due to malaria has been defined. In designing trials of malaria vaccines it is important that, to the extent possible, definitions of both clinical malaria and severe malaria are agreed that have high specificity and good sensitivity. There was general agreement on how these definitions should be determined, which should facilitate the clinical evaluation of vaccine candidates in paediatric populations in malaria endemic countries. There was agreement that trials of products that might be expected to have lower efficacy than most other vaccines in routine use for other diseases was justified as even partially effective malaria vaccines may be an important tool for reducing the large burden of disease due to malaria globally. Such products would be most easily deployed if they were designed to be administered with other EPI vaccines, which would be appropriate as the greatest burden of malaria is in infancy and early childhood. The conduct of pivotal trials poses special challenges both because the expected efficacy of immediately foreseeable vaccines is likely to be less than 50% and while malaria is a very common disease, distinguishing it from other conditions is far from straightforward. Therefore, in order to facilitate the interpretation of the results from trials, in particular for regulatory decision-making, it is essential that, insofar as is possible, methods that are used to define the clinical endpoints in such trials are standardised and validated. Cogent cases can be made for using either uncomplicated malaria disease or severe disease as the primary endpoint in pivotal trials, as both impose an enormous public health burden. The decision on which of these is most appropriate will be influenced by both scientific and non-scientific factors. Public health authorities might be more likely to accelerate introduction of a vaccine if an effect on severe disease had been demonstrated in a pivotal trial. Such decisions would also be influenced by knowledge of the efficacy of the vaccine in different malaria endemic settings and by knowledge of the duration of protection conferred post-vaccination. While phase IV studies may be necessary to generate some of this information, it is important to design pivotal trials to provide this information to the extent possible.
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PMID:Measurement of malaria vaccine efficacy in phase III trials: report of a WHO consultation. 1757 87

Preventive trials (to prevent from infection) or prophylaxis trials (to avoid consequences of the disease) differ from other clinical trials as they apply to healthy subjects or subjects considering themselves as such: the latter do not ask for intervention even less for trial. Moreover, it is generally an experiment which aims at validating a public health intervention, the individual character of which could appear as secondary regarding the collective interest. It concerns many tools or methods: preventive or prophylactic vaccines and drugs, condoms, impregnated bed nets, etc. The field of implementation of preventive trials is large and covers routine immunization (EPI), large-scale control or eradication of endemic diseases or epidemics, for which the concept of individual risk is generally better understood. Preventive trials imply ethical obligations (high individual or collective benefits and absence of risks as there is no immediate therapeutic compensation), methodological adaptations (because the number of subjects is considerably larger than for therapeutic trials) and a sensitive valorization towards a large population who is not asking for the recommended intervention. As regard the benefits, it is also necessary to consider the costs in comparison with the expected efficacy The methodological constraints are important because the demonstration of both safety and efficacy requires a very large number of subjects to validate the product. It is often necessary to use indirect or substitutive markers and indicators (title of protective antibodies rather than definite clinical protection) which need a preliminary validation. Before carrying out a preventive or prophylactic trial, it is advisable to specify the objectives in order to assess the real profits and absence of risks during the trial and after the implementation of the tested product. Preventive trials require a phase of technological transfer to guarantee the application of the validated tools for the benefit of the population at stake. In this respect, if trials for prevention are now well codified both on ethical and methodological aspects, trials for prophylaxis (filariasis with ivermectin, schistosomiasis with praziquantel, malaria with intermittent "preventive" treatment or HIV with antiretroviral treatment, for example) still remain a difficult issue at both ethical and methodological levels.
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PMID:[Defining an ethics for preventive trials]. 1854 98

Inconsistent use of the mosquito nets and other social and technical factors were shown to influence efficacy of mosquito nets at field trials. But to date, experience with local factors influencing effectiveness of ITN programs remain very limited. The objective of this study was to assess the effectiveness of ITNs for preventing clinical malaria in under-five children of Omo Nada Woreda, Jimma Zone South West Ethiopia. Matched case-control study was conducted in the catchments population of Asendabo and Nada health centers, Omo Nada Woreda, South West Ethiopia on a sample of 273 under-five children. Each case of fever and parasitemia in a child was paired with two controls. Cases and controls were compared with regard to ITN ownership and other factors assessed by a pre-coded, pre-tested structured questionnaire. Data was analyzed using EPI-INFO version 3.3.2 software. To control the effect of confounding variables, conditional logistic regression model was used. Sleeping under the mosquito net the night (OR = 8.28 95% CI: 0.96, 71.1) and the week (OR = 2.41 95% CI: 0.41, 14.0) before the survey date were strongly, but not significantly associated with clinical malaria. Mosquito net possession and appropriate utilization of mosquito net were not associated with clinical malaria. In the comparison of cases with all the controls rolling out of mosquito net & corrugated iron roof were found to be independent predictors of clinical malaria. Knowledge about the sign and symptoms of malaria and its modes of transmission were also independent predictors of clinical malaria in comparison of cases with health center and community controls, respectively. With the presence of many programmatic deficiencies like poor ITN distribution and re-treatment services, ITNs were not significantly associated with clinical malaria in under-five children when used during low-transmission period. Further research using a large sample size is required. In line with ITN scale up, information Education Communication (IEC) about the preventive practices against malaria, causes of malaria, treatment and sign and symptoms of malaria should be given to the community.
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PMID:Does Insecticide Treated Mosquito Nets (ITNs) prevent clinical malaria in children aged between 6 and 59 months under program setting? 1895 7

The study explored home management practices for malaria by caregivers in the Military Cantonment, Ojo Lagos. Data was collected using pre-tested Focus Group Discussion guide and interviewer-administered questionnaire. The 400 survey respondents were selected using the systematic sampling method while the discussion participants were purposively selected. Data analysis was done using EPI Info statistical software and thematic approaches. The mean age of respondents was 29 +/- 15.2 years while 89.8% of respondents were biological parents of the index children. High prevalence of malaria all year round caused by mosquitoes bite was indicated by 281 (70.2%) respondents, while 73 (18.3%) of the respondents reported having lost a child under 5 years old to malaria related illnesses. Preventive practices were uncoordinated while awareness and use of ITNs is low. Home management practices of childhood malaria involved the immediate treatment with medicines available in the home. Sharing of left over drugs and herbs were common practices. Home treatment was preferred because of high costs 250 (62.5%), unfriendly attitude of workers 195 (48.8%) and long waiting time 194 (48.5%) in the health facilities. Based on the findings there is the need to institute an awareness programme aimed at improving prompt home management of malaria in the barracks.
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PMID:Management practices of childhood malaria among caregivers in Ojo Military Cantonment, Lagos, Nigeria: implication for child survival. 1972 28

Recent results from the phase 3 trial of RTS,S/AS01 malaria vaccine show that the vaccine induced partial protection against clinical malaria in infants and children; given the high burden of the disease it is currently considered for use in malaria endemic countries. To inform adoption decisions the paper proposes a generalizable methodology to estimate the cost of vaccine introduction using routinely collected and publicly available data from the cMYP, UNICEF, and WHO-CHOICE. Costing is carried out around a set of generic activities, assumptions, and inputs for delivery of immunization services adapted to a given country and deployment modality to capture among other factors the structure of the EPI program, distribution model, geography, and demographics particular to the setting. The methodology is applied to estimate the cost of RTS,S introduction in Burkina Faso, Ghana, Kenya, Senegal, Tanzania, and Uganda. At an assumed vaccine price of $5 per dose and given our assumptions on coverage and deployment strategy, we estimate total economic program costs for a 6-9 months cohort within $23.11-$28.28 per fully vaccinated child across the 6 countries. Net of procurement, costs at country level are substantial; for instance in Tanzania these could add as much as $4.2 million per year or an additional $2.4 per infant depending on the level of spare capacity in the system. Differences in cost of vaccine introduction across countries are primarily driven by differences in cost of labour. Overall estimates generated with the methodology result in costs within the ranges reported for other new vaccines introduced in SSA and capture multiple sources of heterogeneity in costs across countries. Further validation with data from field trials will support use of the methodology while also serving as a validation for cMYP and WHO-CHOICE as resources for costing health interventions in the region.
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PMID:Costing RTS,S introduction in Burkina Faso, Ghana, Kenya, Senegal, Tanzania, and Uganda: A generalizable approach drawing on publicly available data. 2651 6

The RTS,S/AS01 malaria vaccine (Mosquirix) reduces the incidence of Plasmodium falciparum malaria and is intended for routine administration to infants in Sub-Saharan Africa. We evaluated the immunogenicity and safety of 10-valent pneumococcal non-typeable Haemophilus influenzae protein D conjugate vaccine (PHiD-CV; Synflorix) and human rotavirus vaccine (HRV; Rotarix) when co-administered with RTS,S/AS01 ( www.clinicaltrials.gov NCT01345240) in African infants. 705 healthy infants aged 8-12 weeks were randomized to receive three doses of either RTS,S/AS01 or licensed hepatitis B (HBV; Engerix B) vaccine (control) co-administered with diphtheria-tetanus-acellular pertussis-Haemophilus influenzae type-b-conjugate vaccine (DTaP/Hib) and trivalent oral poliovirus vaccine at 8-12-16 weeks of age, because DTaP/Hib was not indicated before 8 weeks of age. The vaccination schedule can still be considered broadly applicable because it was within the age range recommended for EPI vaccination. PHiD-CV or HRV were either administered together with the study vaccines, or after a 2-week interval. Booster doses of PHiD-CV and DTaP/Hib were administered at age 18 months. Non-inferiority of anti-HBV surface antigen antibody seroprotection rates following co-administration with RTS,S/AS01 was demonstrated compared to the control group (primary objective). Pre-specified non-inferiority criteria were reached for PHiD-CV (for 9/10 vaccine serotypes), HRV, and aP antigens co-administered with RTS,S/AS01 as compared to HBV co-administration (secondary objectives). RTS,S/AS01 induced a response to circumsporozoite protein in all groups. Pain and low grade fever were reported more frequently in the PHiD-CV group co-administered with RTS,S/AS01 than PHiD-CV co-administered with HBV. No serious adverse events were considered to be vaccine-related. RTS,S/AS01 co-administered with pediatric vaccines had an acceptable safety profile. Immune responses to RTS,S/AS01 and to co-administered PHiD-CV, pertussis antigens and HRV were satisfactory.
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PMID:Immune response to the hepatitis B antigen in the RTS,S/AS01 malaria vaccine, and co-administration with pneumococcal conjugate and rotavirus vaccines in African children: A randomized controlled trial. 2963 Apr 38


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