Efficacy and safety of 1 and 2 doses of live attenuated influenza vaccine in vaccine-naive children.

BACKGROUND: We investigated the efficacy and safety of 1 versus 2 doses of live attenuated influenza vaccine (LAIV) in influenza vaccine-naive children aged 6 to <36 months. PATIENTS/METHODS: Subjects were randomized to 1 of 4 regimens in year 1: 2 doses LAIV, 1 dose LAIV, excipient placebo, or saline placebo. In year 2, LAIV recipients were to receive 1 dose of LAIV and placebo recipients were to receive saline placebo. Because of an unintended treatment allocation error in year 2, 1 block of subjects who were randomized to LAIV received saline placebo and 1 block who were randomized to placebo received LAIV. RESULTS: In year 1, vaccine efficacy versus placebo among recipients of 2 and 1 doses of LAIV was 73.5% and 57.7%, respectively, against antigenically similar strains. In year 2, absolute efficacy of a single dose of LAIV was 73.6% and 65.2%, respectively, in recipients of 2 and 1 doses of LAIV in year 1. Year 2 efficacy was 57.0% in subjects who received 2 doses of LAIV in year 1 and placebo in year 2. Safety and tolerability of LAIV were consistent with previous studies. Reactogenicity was similar between placebo groups. Seroconversion rates were significantly higher in the 2-dose versus the 1-dose LAIV group in year 1 and in both LAIV groups versus placebo in years 1 and 2. CONCLUSIONS: One dose of LAIV provided clinically significant protection against influenza in young children previously unvaccinated against influenza; 2 doses provided additional protection. Protection after 2 doses in year 1 persisted through a second season without revaccination. LAIV excipients were not a major contributor to reactogenicity. These benefits provide support for increased use of LAIV in children > or =2 years of age.

Immunogenicity of a combined DTPa-HB vaccine co-administered with Haemophilus influenzae type B conjugate vaccine (PRP-T) for primary and booster vaccinations

OBJECTIVE: To evaluate the immunogenicity of a combined DTPa-HB vaccine co-administered with Haemophilus influenzae type b conjugate vaccine (PRP-T) in Brazilian infants. MATERIAL AND METHODS: A prospective and open clinical study, in which 110 infants were immunized with a three-dose primary vaccination regime at two, four and six months of age and with a single booster vaccination. Blood samples were drawn immediately before the first dose, one month after the third dose, at the time of the booster dose and one month after the booster to assess seropositivity and antibody geometric mean titers (GMTs) of antibodies for diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and for the three pertussis antigens: Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN). RESULTS: Among the original 110 infants, 93 completed the study. Seropositivity was 100 percent for all seven involved antibodies, after the primary vaccination course. At the time of the booster dose, all antibodies (except diphtheria 33.7 percent and anti-PT 59 percent) were seropositive for more than 94 percent of subjects. After the booster, seropositivity increased to 100 percent for all antibodies. The GMT of these antibodies followed a similar pattern, with a strong increase after the primary course, followed by a second increase after the booster dose. At this time, GMT was2- to 7-fold higher than after the primary course, for all vaccine components. CONCLUSIONS: Concomitant administration of DTPa-HB and Hib vaccines elicited strong seroprotection for all the antigenic components. No interference with antibody response was evident. The vaccines provided high immunogenicity, following both the primary vaccinations and the booster dose.

Immunogenicity of a combined DTPa-HB vaccine co-administered with Haemophilus influenzae type B conjugate vaccine (PRP-T) for primary and booster vaccinations.

OBJECTIVE: To evaluate the immunogenicity of a combined DTPa-HB vaccine co-administered with Haemophilus influenzae type b conjugate vaccine (PRP-T) in Brazilian infants. MATERIAL AND METHODS: A prospective and open clinical study, in which 110 infants were immunized with a three-dose primary vaccination regime at two, four and six months of age and with a single booster vaccination. Blood samples were drawn immediately before the first dose, one month after the third dose, at the time of the booster dose and one month after the booster to assess seropositivity and antibody geometric mean titers (GMTs) of antibodies for diphtheria, tetanus, hepatitis B, Haemophilus influenzae type b and for the three pertussis antigens: Pertussis Toxin (PT), Filamentous Hemagglutinin (FHA) and Pertactin (PRN). RESULTS: Among the original 110 infants, 93 completed the study. Seropositivity was 100% for all seven involved antibodies, after the primary vaccination course. At the time of the booster dose, all antibodies (except diphtheria 33.7% and anti-PT 59%) were seropositive for more than 94% of subjects. After the booster, seropositivity increased to 100% for all antibodies. The GMT of these antibodies followed a similar pattern, with a strong increase after the primary course, followed by a second increase after the booster dose. At this time, GMT was 2- to 7-fold higher than after the primary course, for all vaccine components. CONCLUSIONS: Concomitant administration of DTPa-HB and Hib vaccines elicited strong seroprotection for all the antigenic components. No interference with antibody response was evident. The vaccines provided high immunogenicity, following both the primary vaccinations and the booster dose.

Mudança de conhecimento de gestantes em aleitamento materno através de atividade educacional / Change of knowledge of pregnant woman in breast-feeding over educational activity

Com o propósito de avaliar a incorporação de conhecimentos sobre o aleitamento materno das gestantes participantes de uma atividade educativa de incentivo ao aleitamento natural, foi realizado estudo tipo antes e depois, considerando-se como intervenção a atividade educativa e as variáveis dependentes aquelas que compõem o questionário aplicado antes e depois da intervenção. A atividade educativa foi realizada em duas Unidades Básicas de Saúde do município de Embu, situado no perímetro urbano da Grande São Paulo, e constituiu-se de uma única sessão, coordenada por pediatra ou enfermeira, de orientação e discussão de grupos de gestantes durante o último trimestre de gestação. Para avaliação das mudanças de conhecimento de 138 gestantes participantes da atividade, foi utilizado um questionário composto de dez perguntas, abrangendo vários tópicos sobre amamentação, aplicado às gestantes antes e após a orientação. A atividade interferiu positivamente na aquisição de conhecimentos das gestantes em todas as questões. A média de acertos que era de 61,2 por cento no pré-teste foi para 85,6 por cento no pós-teste, representando 40 por cento de aumento entre as duas médias. Na aquisição de conhecimentos, observou-se variação estatisticamente significante para p<0,05 em relação à idade da gestante e à paridade. A aquisição de conhecimentos não teve relação com o grau de escolaridade das gestantes. A maior aquisição de conhecimentos ocorreu entre as primíparas e as gestantes menores de 20 anos. Esses subgrupos devem ser considerados prioritários para as atividade educativas de incentivo ao aleitamento.

A experiência do departamento de pediatria da Unifesp no programa de integraçäo docente-assistencial do Embu(SP) / Experience od the Department of Pediatrics, Federal University of Säo Paulo in the Faculty-Assistencial Integration Program of Embu(SP)

O artigo apresenta a Atençäo Primária à Saúde do ponto de vista conceitual, segundo a Conferência Internacional de Alma-Ata (1978), promovida pela Organizaçäo Mundial da Saúde (OMS) e pelo Fundo das Naçöes Unidas para a Infância (Unicef). Posteriormente, foi feita uma análise do processo de implantaçäo do programa de integraçäo docente-assistencial no País, correlacionando esse processo com as significativas mudanças do Sistema de Saúde que, em parte, incorporaram princípios da Atençäo Primária como integralidade das açöes, universalizaçäo, equidade, regionalizaçäo, hierarquizaçäo, referência e contra-referência e controle social. Finalmente, foi apresentado o Programa de Integraçäo Docente-Assistencial realizado no município de Embu (Regiäo Metropolitana de Säo Paulo), desenvolvido pela Disciplina de Pediatria Geral e Comunitária do Departamento de Pediatria da Universidade Federal de Säo Paulo, com atuaçäo na graduaçäo e residência médica de Pediatria.