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1.
Arch. argent. pediatr ; 115(1): e13-e16, feb. 2017. ilus
Article in Spanish | LILACS, BINACIS | ID: biblio-838322

ABSTRACT

El síndrome de Nicolau, también conocido como embolia cutis medicamentosa o dermatitis livedoide, es una reacción cutánea infrecuente, caracterizada por una necrosis de la piel y los tejidos blandos de aparición súbita luego de la aplicación intramuscular de algunas drogas. Presentamos a un bebé de 6 meses de edad que, al recibir la tercera dosis de la vacuna séxtuple intramuscular, desarrolló una lesión necrótica con reticulado violáceo periférico en el sitio de aplicación. Se destaca la importancia del diagnóstico precoz a fin de instaurar un adecuado tratamiento y seguimiento para evitar complicaciones secundarias a la isquemia.


Nicolau syndrome, also known as embolia cutis medicamentosa or livedo-like dermatitis, is a sudden tissue necrosis, a rare complication of intramuscular injection of some drugs. We report a case of a 6-month-old girl who received intramuscularly the third dose of hexavalent vaccine (DTaP-HVB-IPV/HIb), and immediately presented a livedoid lesion around the injection site, progressing to necrosis. We reinforce the importance of early diagnosis to perform a suitable treatment and clinical follow-up to avoid ischemic secondary complications.


Subject(s)
Humans , Female , Infant , Nicolau Syndrome/etiology , Poliovirus Vaccine, Inactivated/administration & dosage , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Hepatitis B Vaccines/administration & dosage , Vaccines, Combined/administration & dosage , Haemophilus Vaccines/administration & dosage , Injections, Intramuscular/adverse effects
2.
Rev. cuba. enferm ; 31(3): 0-0, jul.-set. 2015.
Article in Spanish | LILACS, BDENF, CUMED | ID: lil-797692

ABSTRACT

Objetivo: evaluar la efectividad de la aplicación de un método de distracción audiovisual sobre el nivel de dolor en niños de 4 años durante la administración de la vacuna Triple Vírica en una zona de salud de Extremadura. Método: ensayo controlado aleatorizado. Fueron estudiados dos grupos de niños/as de cuatro años: Grupo intervención (n1=25) y grupo control (n2=25). La intervención consistió en la aplicación de un método de distracción audiovisual durante la administración de la vacuna. Se evaluó la intensidad del dolor según dos escalas: Cheops y Dibujos Faciales. Se registraron las variaciones de Tensión Arterial y Frecuencia Cardíaca. Resultados: el grupo intervenido mostró significativamente menor intensidad de dolor al ser comparado con el grupo control, tanto en la Escala Cheops como en la Escala de Dibujos Faciales. También se hallaron diferencias significativas en la variación de la Tensión Arterial y Frecuencia Cardíaca. Conclusiones: la distracción audiovisual fue una efectiva intervención para disminuir la intensidad de dolor durante la administración de la vacuna Triple Vírica. Sería necesario potenciar el desarrollo de estrategias de distracción en muchos procedimientos dolorosos, sobre todo en niños(AU)


Objectives: to evaluate the effectiveness of applying a method of audiovisual distraction about the pain level in four-year-old children during the administration of the MMR vaccine in a health zone of Extremadura. Method: randomized controlled trial design. Two groups of four-year-old children were studied: Intervention group (n1=25) and control group (n 2=25). The intervention consisted of the application of a method of audiovisual distraction during the administration of the vaccine. The intensity of pain was measured with two scales: CHEOPS and facial drawings. It was also measured variations of blood pressure and heart rate. Results: the intervention group showed significantly lower pain when compared with the control group, both the scale CHEOPS and the scale facial drawings. Also, it was found statistical significant differences in the blood pressure and heart rate. Conclusions: the audiovisual distraction it was an effective method to decrease pain intensity of such procedure. It would be necessary to enhance the development of distraction strategies in many painful procedures, especially in children(AU)


Subject(s)
Humans , Male , Female , Child, Preschool , Audiovisual Aids , Teaching Materials , Pain Measurement/methods , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage
4.
J. pediatr. (Rio J.) ; 91(4): 333-338, July-Aug. 2015. tab, ilus
Article in English | LILACS | ID: lil-759340

ABSTRACT

OBJECTIVE: Report the incidence, epidemiology, clinical features, death, and vaccination status of patients with whooping cough and perform genotypic characterization of isolates of B. pertussis identified in the state of Paraná, during January 2007 to December 2013.METHODS: Cross-sectional study including 1,209 patients with pertussis. Data were obtained through the Notifiable Diseases Information System (Sistema de Informação de Agravos de Notificação - SINAN) and molecular epidemiology was performed by repetitive sequence-based polymerase chain reaction (rep-PCR; DiversiLab(r), bioMerieux, France).RESULTS: The incidence of pertussis in the state of Paraná increased sharply from 0.15-0.76 per 100,000 habitants between 2007-2010 to 1.7-4.28 per 100,000 between 2011-2013. Patients with less than 1 year of age were more stricken (67.5%). Fifty-nine children (5%) developed pertussis even after receiving three doses and two diphtheria-tetanus-pertussis (DTP) boosters vaccine. The most common complications were pneumonia (14.5%), otitis (0.9%), and encephalopathy (0.7%). Isolates of B. pertussis were grouped into two groups (G1 and G2) and eight distinct patterns (G1: P1-P5 and G2: P6-P8).CONCLUSION: The resurgence of pertussis should stimulate new research to develop vaccines with greater capacity of protection against current clones and also encourage implementation of new strategies for vaccination in order to reduce the risk of disease in infants.


OBJETIVO: Relatar a incidência, os aspectos epidemiológicos, clínicos, a morte e a vacinação de pacientes com coqueluche e fazer a caracterização genotípica de isolados de Bordetella pertussisidentificados no Estado do Paraná, de janeiro de 2007 a dezembro de 2013.MÉTODOS: Estudo transversal, incluindo 1.209 pacientes com coqueluche. Os dados foram obtidos no Sistema de Informação de Agravos de Notificação (Sinan) e a epidemiologia molecular foi feita por PCR baseada em sequências repetitivas (rep-PCR; DiversiLab(r), bioMerieux, France).RESULTADOS: A incidência de coqueluche no Estado do Paraná aumentou acentuadamente de 0,15-0,76 por 100.000 habitantes entre 2007-2010 para 1,7-4,28 por 100.000 habitantes entre 2011-2013. Os pacientes com menos de um ano foram os mais afetados (67,5%); 59 crianças (5%) desenvolveram coqueluche mesmo depois de receber três doses da vacina e dois reforços com a vacina tríplice DTP. As complicações mais comuns foram pneumonia (14,5%), otite (0,9%) e encefalopatia (0,7%). Isolados de B. pertussis foram agrupados em dois grupos (G1 e G2) e oito padrões distintos (G1: P1-P5 e G2: P6-P8).CONCLUSÃO: O ressurgimento da coqueluche vem para sugerir novas pesquisas com o objetivo se desenvolverem vacinas com maior capacidade de proteção contra os clones atuais e também implantar novas estratégias de vacinação, a fim de reduzir o risco de doenças em lactentes.


Subject(s)
Adolescent , Adult , Aged , Child , Child, Preschool , Female , Humans , Infant , Infant, Newborn , Male , Middle Aged , Bordetella pertussis/genetics , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Vaccination/statistics & numerical data , Whooping Cough/epidemiology , Age Distribution , Bordetella pertussis/isolation & purification , Brazil/epidemiology , Cross-Sectional Studies , Cyanosis/complications , Hospitalization/statistics & numerical data , Immunization Schedule , Incidence , Pneumonia/complications , Repetitive Sequences, Nucleic Acid , Sequence Analysis, DNA , Whooping Cough/complications , Whooping Cough/prevention & control
5.
Ciênc. Saúde Colet. (Impr.) ; 20(2): 441-448, fev. 2015. tab
Article in Portuguese | LILACS | ID: lil-742219

ABSTRACT

Objetivou-se analisar as internações por condições sensíveis à atenção primária (ICSAP) específicas em mulheres e os fatores que determinam ou influenciam a ocorrência dessas internações (fatores socioeconômicos, sociodemográficos e controle de saúde) por meio de um inquérito de morbidade hospitalar realizado com amostra de 429 mulheres internadas em hospitais conveniados ao Sistema Único de Saúde. O percentual de ICSAP foi 49,42% (n = 212), com destaque para as internações específicas do sexo feminino 19,35% (n = 83). Associaram ao risco de internar por CSAP: idade superior a 60 anos, baixa escolaridade, internação prévia, realização de controle regular de saúde, falta de vínculo com a Estratégia Saúde da Família (ESF) e ser gestante. As causas evidentes foram as condições relacionadas à gravidez, ao parto e ao puerpério e às inflamações nos órgãos pélvicos femininos. Os resultados sugerem falhas no atendimento ambulatorial que deveria ser oportuno e resolutivo no contexto da saúde da mulher.


The scope of this paper was to analyze female-specific sensitive hospitalization occurring in primary care conditions and factors that determine or affect the occurrence of such hospitalizations (social, economic and demographic factors; health control). Analysis was performed by surveys on hospital morbidity with a sample of 429 females attended in Unified Health System (SUS) contracted hospitals. The sensitive hospitalizations percentage in primary care reached 49.42% (n = 212), highlighting female-specific hospitalization at 19.35% (n = 83). Hospitalization risks comprised elderly people over sixty, low schooling, previous hospitalizations, normal health control, lack of association with the Family Health Strategy and pregnancy. Evident causes were related to conditions of pregnancy, childbirth, post-partum and inflammations of the female pelvic organs. Results suggested flaws in outpatient attendance that should be adequate and provide solutions in women’s health.


Subject(s)
Humans , Infant , Bacterial Proteins/immunology , Carrier Proteins/immunology , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Diphtheria-Tetanus-Pertussis Vaccine/immunology , Haemophilus Vaccines/adverse effects , Haemophilus Vaccines/immunology , Immunoglobulin D/immunology , Lipoproteins/immunology , Pneumococcal Vaccines/adverse effects , Pneumococcal Vaccines/immunology , Poliovirus Vaccine, Inactivated/adverse effects , Poliovirus Vaccine, Inactivated/immunology , Antibodies, Bacterial/immunology , Antibodies, Viral/immunology , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Haemophilus Vaccines/administration & dosage , Immunization Schedule , Netherlands , Pneumococcal Vaccines/administration & dosage , Poliovirus Vaccine, Inactivated/administration & dosage , Vaccination , Vaccines, Combined/administration & dosage , Vaccines, Combined/adverse effects , Vaccines, Combined/immunology , Vaccines, Conjugate
6.
Rev. chil. infectol ; 31(4): 385-392, ago. 2014. graf, tab
Article in Spanish | LILACS | ID: lil-724807

ABSTRACT

Introduction: Pertussis, a vaccine-preventable respiratory disease, remains a public health problem. Objective: The goal of this study is to describe epidemiological and clinical patterns of B. pertussis-caused respiratory infection over the period 2006-2010 in Santa Fe, Argentina. Methods: Inpatients and outpatients < 14 years of age, meeting pertussis case definition criteria were included. Household family contacts of confirmed cases with compatible symptoms were also surveyed. Results: 1074 patients were evaluated, 102 (9.49%) were confirmed through PCR. The proportion of confirmed cases was: in 2006, 35.5%; 2007, 21.2%; 2008, 4.9%. In 2009 and 2010 no cases were detected. 94.2% of hospitalized patients and 42.8% of outpatients were less than six months of age. Of all patients, 67.6% required hospitalization as they had a moderate to severe illness. The length of stay for these patients was over six days. 27.5% had pre-existing medical conditions, the most frequent being prematurity and malnutrition. The outcome was severe in 23.1% of cases, all of whom hadn't started the vaccination schedule. Severe pulmonary hypertension was present in five patients. Fatality rate was 4.9%. Conclusions: Pertussis mainly affected children < 6 months, non-vaccinated or with less than 3 doses. The bacterium was also detected among adults and teenagers.


Introducción: Tos convulsiva es una enfermedad respiratoria prevenible por vacuna, que continúa siendo un problema de salud pública. Objetivo: Describir el patrón clínico y epidemiológico de la infección respiratoria por Bordetella pertussis durante el período 2006-2010 en Santa Fe, Argentina. Material y Métodos: Se incluyeron pacientes internados y ambulatorios menores de 14 años, que cumplieron con los criterios de definición de caso de coqueluche y los contactos de casos confirmados. Resultados: Se evaluaron 1.074 pacientes, 102 (9,49%) fueron confirmados por RPC. La proporción de casos confirmados fue: en 2006: 35,5%; 2007: 21,2%; 2008: 4,9%. En los años 2009 y 2010 no se detectaron casos. El 67,6% requirió internación con una duración de 6 días. El 94,2% de los pacientes hospitalizados fue menor de 6 meses y en los ambulatorios el 42,8%. El 27,5% presentaba condiciones médicas pre-existentes, siendo prematuridad y desnutrición las más frecuentes. La evolución de la enfermedad fue grave en 23,1% de los casos, los cuales no habían iniciado el calendario de vacunaciones. Se presentó hipertensión pulmonar grave en 5 pacientes. La letalidad fue de 4,9%. Discusión: La enfermedad afectó principalmente a lactantes < 6 meses, no vacunados o con menos de 3 dosis. La bacteria también se detectó entre adultos y adolescentes.


Subject(s)
Adolescent , Adult , Child , Child, Preschool , Humans , Infant , Young Adult , Whooping Cough/epidemiology , Argentina/epidemiology , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Risk Factors , Seasons , Severity of Illness Index , Whooping Cough/diagnosis
7.
Santiago de Chile; Chile. Ministerio de Salud; 26 ene. 2012. 2 p.
Non-conventional in Spanish | LILACS, MINSALCHILE | ID: biblio-1544097

ABSTRACT

Modifícase el decreto Nº6, de 2010, del Ministerio de Salud, que dispone la vacunación obligatoria de la población contra las enfermedades inmunoprevenibles que se indican, reemplazando en su punto Nº 1, los numerales 3, 4, 5 y 11, respectivamente, en la forma que se indica.


Subject(s)
Humans , Immune System Diseases , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Chile , Whooping Cough/prevention & control , Diphtheria/prevention & control , Tetanus/prevention & control
8.
Rio de Janeiro; s.n; 2011. 88 p. tab.
Thesis in Portuguese | LILACS | ID: lil-657307

ABSTRACT

Neisseria meningitidis é uma das principais causas de meningite bacteriana e septicemia em todo o mundo, acometendo principalmente crianças menores de 4 anos. Atualmente, não existe uma vacina universal contra o meningococo B (MenB). A imunidade protetora contra o meningococo caracteriza-se pela presença e persistência de anticorpos bactericidas, porém pouco se sabe sobre os mecanismos de desenvolvimento desta memória sorológica. Avaliamos em modelo animal e em humanos, a geração e manutenção das células secretoras de anticorpos (ASC) e dos linfócitos B de memória (LBm) após vacinação contra MenB. Utilizamos como referência a vacina diftérica (dt ou DTP), considerada ter ótima eficácia em humanos. Para o estudo em modelo animal, grupos de 6 a 8 camundongos suíços, fêmeas, de 5 a 6 semanas, foram imunizados com 3 doses da vacina VA-MENGOC-BC ou DTP, via intramuscular, com intervalo de 2 semanas entre as doses. Aproximadamente 2, 4 ou 6 meses após a última dose, os animais receberam a dose reforço. A vacina anti-MenB induziu uma resposta primária de ASC maior que a resposta à dose reforço. Ao contrário, a resposta de ASC à vacina dT foi maior após o booster. A resposta de LBm anti-MenB permaneceu constante (média de 1%) ao longo de todo o estudo, mas a resposta ao toxóide diftérico (TD) foi maior após o booster (média de 1,9%) que após a imunização primária. A concentração de IgC, anticorpos bactericidas e opsonizantes contra MenB foi dose-dependente e foi reativada após a administração das doses reforços. Esses resultados sugerem que os LBm presentes no baço foram responsáveis pela forte resposta de anticorpos observada após a dose reforço. Para o TD, ambas ASC e LBm foram importantes na manutenção da memória sorológica. Para o estudo em humanos, seis voluntários foram imunizados com 3 doses da vacina VA-MENGOC-BC, via intramuscular, com intervalo de 6 a 7 semanas entre as doses. Seis meses após a imunização primária, os indivíduos receberam uma dose...


Neisseria meningitides is one of the leading causes of bacterial meningitis and septicemia worldwide, particularly in children less than four years old. Currently, there is no universal vaccine agoinst serogroup B meningococcus (MenB). Protective immunity against meningococcus is characterized by the presence and persistence of bactericidal antibody, but little is known about the mechanisms of development of the serological memory. In this study, we evaluated in animal model and in humans the generation and maintenance of antibody secreting cells (ASC) and memory B cell after vaccination against MenB. We used the diphtheria vaccine (dT or DTP) as a reference for efficacy in humans. Five to six-week old female Swiss mice in groups of 6 to 8 were immunized with three intramuscular injections of VA-MENGOC-BC or DTP vaccine 2 weeks apart. Approximately 2, 4 or 6 months after the last dose, mice received a booster injection of the vaccine. Vaccination against MenB induced a higher ASC primary response compared with the booster response. In contrast, ASC response to dT was higher after booster than after primary immuinization. Memory B-cell to MenB remained at constant levels (mean of 1%) during the whole study, but the response to diphtheria toxoid (TD) was higher after boosting (mean of 1.9%) when compared with the primary response. IgG, bactericidal and opsonic antibody concentrations to MenB was dose-dependent and was reactivated after booster doses. These data suggest that spleen memory B-cells were responsible for the strong boosting antibody response to MenB. For TD, both ASC and memory B-cell were important for maintenance of the serological memory. For the human study, six volunteers were immunized with three intramuscular injections of VA-MENGOC-BC 6 to 8 weeks apart. Six months after the last dose, subjects received a booster dose. Another group of volunteers (n=5) were immunized with a booster dose of dT vaccine. Three doses of vaccine...


Subject(s)
Humans , Animals , Male , Female , Rats , Antibodies, Bacterial/immunology , Immunologic Memory , Neisseria meningitidis, Serogroup B/immunology , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Meningococcal Vaccines/administration & dosage , Dose-Response Relationship, Immunologic , Injections, Intramuscular , B-Lymphocytes/immunology , Meningitis, Meningococcal/etiology
10.
Rev. panam. salud pública ; 27(2): 117-124, feb. 2010. ilus, tab
Article in English | LILACS | ID: lil-542066

ABSTRACT

Objectives:To compare the safety and immunogenicity of a booster dose of a fully liquid diphtheria-tetanus-whole cell pertussis-hepatitis B-Haemophilus influenzae type b (DTPw-HepB-Hib) vaccine to the separate administration of commercially available DTPw and Hib vaccines in healthy toddlers. Methods:An open-label, randomized, parallel-group, Phase III study conducted at six centers in San Salvador, El Salvador, during February-June 2006. Toddlers (15-24 months of age) were eligible to participate if they had received primary immunization at 2, 4, and 6 months of age with a commercial DTPw-HepB/Hib vaccine requiring reconstitution. Participants received either one booster dose of DTPw-HepB-Hib fully liquid vaccine or DTPw and Hib vaccines administered separately. Blood samples were taken immediately prior to and at 1 month post-vaccination. For a 5-day period following vaccination, solicited adverse events were collected in subject diaries and assessed. Results:The combined DTPw-HepB-Hib fully liquid vaccine was non-inferior to the separately administered DTPw and Hib vaccines, in terms of seroprotection/seroconversion rates for all antigens evaluated. The combination vaccine elicited a strong booster response as demonstrated by a large increase in antibodies against all vaccine antigens. The geometric mean concentrations (GMCs) of all antibodies in the DTPw-HepB-Hib group exceeded the seroprotection/seroconversion thresholds by very large margins, although for some antigens they were somewhat lower than the corresponding titers in the comparator group. With the combination vaccine, considerably fewer solicited local and systemic adverse events, such as fever and irritability, were reported than with the comparator vaccines. Conclusions:This study demonstrates that the fully liquid combined DTPw-HepB-Hib vaccine is highly immunogenic and has a favorable safety profile when given as a booster vaccination to toddlers who have received...


Objetivos:Comparar la seguridad y la inmunogenicidad en infantes saludables de una dosis de refuerzo de una vacuna líquida combinada contra la difteria, el tétanos, la tosferina (de células enteras), la hepatitis B y Haemophilus influenzae tipo b (DTPw-HepB-Hib), con la aplicación por separado de vacunas DTPw y Hib disponibles comercialmente. Métodos:Se realizó un estudio de fase III abierto, aleatorizado, con grupos paralelos, en seis centros de San Salvador, El Salvador, en febrero-junio de 2006. Los infantes (de 15-24 meses) habían recibido la inmunización primaria a los 2, 4 y 6 meses de edad con una vacuna comercial DTPw-HepB/Hib que necesitaba reconstitución. Los lactantes recibieron una dosis de refuerzo con la vacuna DTPw-HepB-Hib o las vacunas DTPw y Hib por separado. Se tomaron muestras de sangre inmediatamente antes de la vacunación y un mes después. Las reacciones adversas en los cinco días siguientes a la vacunación se anotaron en diarios individuales y se evaluaron. Resultados:Según las tasas de seroprotección/seroconversión de todos los antígenos evaluados, la vacuna DTPw-HepB-Hib no fue inferior que las vacunas DTPw y Hib administradas por separado. La vacuna combinada produjo una fuerte respuesta de refuerzo, reflejada en el gran aumento de anticuerpos contra todos los antígenos presentes. Con respecto al grupo de comparación, en el grupo vacunado con DTPw-HepB-Hib las concentraciones geométricas medias de todos los anticuerpos superaron ampliamente los umbrales de seroprotección/seroconversión -aunque con títulos menores en algunos antígenos- y hubo mucho menos reacciones adversas locales y sistémicas, como fiebre e irritabilidad. Conclusiones:Se demostró que la vacuna líquida combinada DTPw-HepB-Hib es altamente inmunógena y satisfactoriamente segura cuando se aplica como dosis de refuerzo a infantes inmunizados primariamente con una vacuna pentavalente diferente que requiere reconstitución.


Subject(s)
Female , Humans , Infant , Male , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Diphtheria-Tetanus-Pertussis Vaccine/immunology , Haemophilus Vaccines/administration & dosage , Haemophilus Vaccines/immunology , Hepatitis B Vaccines/administration & dosage , Hepatitis B Vaccines/immunology , Immunization, Secondary , El Salvador , Vaccines, Combined
13.
Mem. Inst. Oswaldo Cruz ; 103(7): 711-718, Nov. 2008. ilus, tab
Article in English | LILACS | ID: lil-498381

ABSTRACT

A randomized, double-blinded study evaluating the immunogenicity, safety and consistency of production of a combined diphtheria-tetanus-pertussis-Haemophilus influenzae type b vaccine entirely produced in Brazil by Bio-Manguinhos and Instituto Butantan (DTP/Hib-BM) was undertaken. The reference vaccine had the same DTP vaccine but the Hib component was produced using purified materials supplied by GlaxoSmithKline (DTP/Hib-GSK), which is registered and has supplied the Brazilian National Immunization Program for over more than five years. One thousand infants were recruited for the study and received vaccinations at two, four and six months of age. With respect to immunogenicity, the vaccination protocol was followed in 95.6 percent and 98.4 percent of infants in the DTP/Hib-BM and DTP/Hib-GSK groups, respectively. For the Hib component of the study, there was 100 percent seroprotection (>0.15 µg/mL) with all three lots of DTP/Hib-BM and DTP/Hib-GSK. The geometric mean titer (GMT) was 9.3 µg/mL, 10.3 µg/mL and 10.3 µg/mL for lots 1, 2 and 3 of DTP/Hib-BM, respectively, and the GMT was 11.3 g/mL for DTP/Hib-GSK. For diphtheria, tetanus and pertussis, seroprotection was 99.7 percent, 100 percent and 99.9 percent, respectively, for DTP/Hib-BM, three lots altogether and 99.2 percent, 100 percent and 100 percent for DTP/Hib-GSK. GMTs were similar across all lots and vaccines. Adverse events rates were comparable among the vaccine groups. The Brazilian DTP/Hib vaccine demonstrated an immunogenicity and reactogenicity profile similar to that of the reference vaccine.


Subject(s)
Female , Humans , Infant , Male , Diphtheria-Tetanus-Pertussis Vaccine/immunology , Diphtheria/prevention & control , Haemophilus Infections/prevention & control , Haemophilus Vaccines/immunology , Tetanus/prevention & control , Whooping Cough/prevention & control , Bordetella pertussis/immunology , Clostridium tetani/immunology , Corynebacterium diphtheriae/immunology , Double-Blind Method , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Haemophilus Vaccines/administration & dosage , Haemophilus Vaccines/adverse effects , Haemophilus influenzae type b/immunology , Time Factors
14.
Indian Pediatr ; 2008 Oct; 45(10): 819-23
Article in English | IMSEAR | ID: sea-15846

ABSTRACT

OBJECTIVE: To evaluate the safety and immunogenicity of an indigenous hepatitis B, diphtheria, tetanus and B. pertussis tetravalent vaccine (Shantetra) in comparison with Tritanrix HBTM in healthy Indian infants. DESIGN: Multicentric, randomized, single blind intention-to-treat study with 12-18 weeks of follow up period. SETTING: 5 out patient departments at tertiary care referral centers across India. PARTICIPANTS: 151 infants were randomized in a 2:1 ratio to recruit 101 in the Shantetra and 50 in the Tritanrix HBTM groups respectively. A total of 136 subjects completed the study. No patients were withdrawn from the study due to any adverse effects. INTERVENTIONS: Recruited subjects were randomized to receive three doses of either of the two DTPw-Hepatitis B combination vaccines as per the EPI schedule. MAIN OUTCOME MEASURES: Monitoring the humoral immune response (seroconversion rates) induced by each antigenic component three to six weeks after the last dose of vaccine in both the groups. RESULTS: Seroprotective immune response was observed in 98.9% subjects for diphtheria, tetanus and hepatitis B components in the Shantetra group as compared to 95.5% subjects in the Tritanrix HB group. Anti pertussis antibody response was seen in 89% and 91.1% in the Shantetra and Tritanrix HB groups, respectively. The commonly observed adverse events in both the groups were, pain at injection site, mild fever and transient crying.CONCLUSION:The safety and immunogenicity of indigenously developed DTPwHepatitis B combination vaccine was demonstrated in the present study.


Subject(s)
Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Hepatitis B Vaccines/administration & dosage , Humans , India , Infant , Single-Blind Method , Vaccines, Combined
16.
Southeast Asian J Trop Med Public Health ; 2008 May; 39(3): 474-83
Article in English | IMSEAR | ID: sea-30902

ABSTRACT

Malaysian infants would have to receive nine injections during the first few months of life in order to be protected against disease caused by hepatitis B (HBV), diphtheria, tetanus, pertussis and Haemophilus influenzae type b (Hib) if single HBV and Hib vaccines were used. We evaluated a combined DTPw-HBV/Hib vaccine administered at 1.5, 3 and 5 months after a birth dose of hepatitis B vaccine (HBV). One month after completion of the primary vaccination, 99% of subjects had seroprotective anti-HBV antibody levels, and at least 98% had seroprotective antibodies against diphtheria, tetanus, and Hib, and were seropositive for pertussis antibodies. The immune response to the combined vaccine was comparable to that induced by separate injections with DTPw, HBV and Hib vaccines. Overall, the DTPw-HBV/Hib vaccine was as well tolerated as separate administration of DTPw, HBV and Hib vaccines. The combined DTPw-HBV/Hib vaccine induces protection against five diseases as recommended in the Malaysian routine vaccination schedule. Use of the combined DTPw-HBV/Hib vaccine can reduce the required number of injections from nine to four in the first few months of life.


Subject(s)
Antibodies, Bacterial/blood , Antibodies, Viral/blood , Antibody Formation , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Dose-Response Relationship, Immunologic , Enzyme-Linked Immunosorbent Assay , Haemophilus Vaccines/administration & dosage , Hepatitis B Vaccines/administration & dosage , Humans , Immunization Schedule , Infant , Infant, Newborn , Injections, Intramuscular , Malaysia , Radioimmunoassay , Vaccines, Combined/administration & dosage , Vaccines, Conjugate/adverse effects
17.
Acta pediátr. costarric ; 20(2): 81-87, 2008.
Article in Spanish | LILACS | ID: lil-637460

ABSTRACT

Alrededor del mundo, bordetella pertussis representa la quinta causa de muertes prevenibles por vacunación en niños menores de 5 años. Durante las últimas décadas se ha producido un cambio importante en la epidemiología de la enfermedad, donde actualmente los adolescentes y adultos son la fuente de transmisión más importante para infantes menores de 6 meses de edad. La morbimortalidad, complicaciones y número de hospitalizaciones son mayores sobre todo en infantes menores de 2 meses, quienes aún no han recibido su primera inmunización. Por esta razón, dentro de las recomendaciones actuales para tratar de disminuir el impacto de esta enfermedad en este grupo etario, se incluyen la vacunación a personas de alto riesgo de transmisión tales como los adolescentes, adultos, y mujeres en posparto inmediato, estrategia capullo. Esta revisión analiza las últimas recomendaciones al respecto, y se discuten otras estrategias potenciales como la vacunación a embarazadas, recién nacidos, o el aceleramiento del esquema de vacunación contra tosferina. Igualmente se discute su potencial impacto en Costa Rica, donde desde finales del año 2005 se ha presentado el brote más severo de tosferina durante las últimas 4 décadas, con 18 infantes fallecidos a la fecha


Subject(s)
Humans , Immunotherapy, Active , National Health Strategies , Health Strategies , Vaccines , Pertussis Vaccine/administration & dosage , Pertussis Vaccine/adverse effects , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Whooping Cough
18.
Indian Pediatr ; 2007 Dec; 44(12): 916-8
Article in English | IMSEAR | ID: sea-12949

ABSTRACT

This study was designed to evaluate seroprevalence rates of antibodies to pertussis in mothers and their infants, and the immunogenicity of pertussis vaccine in the presence or absence of pertussis antibodies in infants. Blood samples were collected from 110 mother-infants pairs before the first dose of pertussis vaccination and from 69 infants 4-8 weeks after administration of the third dose of DTwP vaccine. Pertussis antibodies were >25 U/mL in 88(78.9%) mothers and 50(45.3%) infants with a mean titer of 67(SD 48.1) and 33.5 (34.7) U/mL, respectively. After administration of three doses of DTwP vaccine, 53(76.8%) infants were seroconverted (MCA titer 87.4 (51.3)U/mL. Immunologic response to vaccination was similar between the two groups of infants; 30/37 (81.1%) of seronegative infants and 23/32 (71.9%) of seropositive infants at pre-vaccination, showed seroconversion after the vaccination (P = 0.36). The results of this study demonstrated that most of the studied mothers were serologically immune to pertussis, and this immunity was transferred to their infants. Pre-vaccination antibody did not affect infants immune response to vaccination.


Subject(s)
Adult , Antibodies, Bacterial/blood , Bordetella pertussis/immunology , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Female , Humans , Immunoglobulin G , Infant , Pilot Projects , Seroepidemiologic Studies , Vaccination , Whooping Cough/blood
19.
J. pediatr. (Rio J.) ; 83(6): 523-528, Nov.-Dec. 2007. tab
Article in English, Portuguese | LILACS | ID: lil-472613

ABSTRACT

OBJETIVO: Avaliar a segurança da vacina combinada de difteria-tétano-coqueluche de células inteiras e Haemophilus influenzae tipo b usada no Programa Nacional de Imunizações, e em especial a incidência de episódios hipotônicos-hiporresponsivos. MÉTODO: Acompanhamento de uma coorte de 21.064 lactentes (20.925 ou 99,7 por cento aderiram ao protocolo de estudo), nas 48 horas após a aplicação da vacina de difteria, tétano, coqueluche de células inteiras e Haemophilus influenzae tipo b em centros de saúde na cidade do Rio de Janeiro, para determinar e investigar eventos adversos graves, espontâneos e solicitados. Cada criança foi monitorada durante somente uma dose. RESULTADOS: A incidência de episódios hipotônicos-hiporresponsivos foi de 1:1.744 doses (casos confirmados) e de 1:1.495 doses (casos confirmados mais casos suspeitos). A taxa de incidência de convulsões foi de 1:5.231 doses. Não foram detectados casos de apnéia. Esses resultados são comparáveis àqueles relatados na literatura para a vacina contra difteria-tétano-coqueluche de células inteiras. CONCLUSÃO: A vacina contra difteria, tétano, coqueluche de células inteiras e Haemophilus influenzae tipo b em estudo pode ser usada com segurança no Programa Nacional de Imunizações, de acordo com as precauções e contra-indicações correntes.


OBJECTIVE:To evaluate the safety of a combined diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine used on the Brazilian National Immunizations Program, chiefly the incidence of hypotonic-hyporesponsive episodes. METHOD: Follow-up of a cohort of 21,064 infants (20,925 or 99.7 percent adhered to the study protocol), within 48 hours of vaccination with diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine in health care units in the City of Rio de Janeiro, to ascertain and investigate spontaneous and solicited severe adverse events. Each child was followed-up for one dose only. RESULTS: The rate of hypotonic-hyporesponsive episodes was 1/1,744 doses (confirmed cases) and 1/1,495 doses (confirmed plus suspect cases). The rate of convulsions was 1/5,231 doses. No cases of apnea were detected. These results are comparable to those found in the literature with diphtheria-tetanus-whole cell pertussis vaccine. CONCLUSION: The diphtheria-tetanus-whole cell pertussis-Haemophilus influenzae type b vaccine under study can be safely used in the National Immunizations Program, according to the current precautions and contraindications.


Subject(s)
Female , Humans , Infant , Male , Diphtheria-Tetanus-Pertussis Vaccine/adverse effects , Fever/etiology , Haemophilus Vaccines/adverse effects , Immunization Programs/statistics & numerical data , Seizures/etiology , Brazil/epidemiology , Cohort Studies , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Diphtheria/prevention & control , Fever/epidemiology , Haemophilus Infections/prevention & control , Haemophilus Vaccines/administration & dosage , Incidence , Interviews as Topic , Severity of Illness Index , Seizures/epidemiology , Tetanus/prevention & control , Whooping Cough/prevention & control
20.
Article in English | IMSEAR | ID: sea-40009

ABSTRACT

OBJECTIVE: Comparing the immunogenicity and reactogenicity of three vaccine combinations. These were GlaxoSmithKline Biologicals' (GSK) Haemophilus influenzae type b vaccine (Hib-TT, Hiberix) administered with the local Government Pharmaceutical Organization's (GPO) diphtheria-tetanus-pertussis whole cell (DTPw) vaccine, Hib-TT mixed with GPO's DTPw vaccine, or Hib-IT mixed with GSKs' DTPw vaccine (Tritanrix). MATERIAL AND METHOD: An open, randomized, controlled, single center study of three hundred and sixty infants. They were randomized into three groups to receive either Hib-TT Hiberix mix with GPOs' DTPw vaccine (group 1), Hib-TT mixed with GPO's DTPw vaccine (group 2), or Hib-TT mixed with GSKs' DTPw vaccine (Tritanrix; group 3) at two, four and six months of age. RESULT: One month after the third dose, all subjects had antibodies level against Hib polyribosylribitol phosphate (PRP) > or = 0.15 microg/ml. All 11 subjects except two (in group 2) had anti-PRP levels > or = 1.0 microg/ml. The geometric mean concentrations were similar in all three groups. Over 96% of the subjects in all three groups demonstrated an immunological response to diphtheria, tetanus, and pertussis antigens. There was no diference among the three groups in terms of severe local reaction and fever. CONCLUSION: The present study showed that the combined vaccines produced an effective antibody response with no increase in reactogenicity compared to separately administrated vaccines.


Subject(s)
Antibodies, Bacterial , Diphtheria-Tetanus-Pertussis Vaccine/administration & dosage , Drug Interactions , Female , Haemophilus Infections/immunology , Haemophilus Vaccines/administration & dosage , Haemophilus influenzae type b/immunology , Humans , Infant , Male , Tetanus Toxoid/administration & dosage , Thailand , Vaccines, Combined
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