A análise do clima escolar como paradigma para um novo cuidado / The analysis of the school climate as a paradigm for new care / El análisis del clima escolar como paradigma de la nueva atención

Introdução:A percepção do significado da escola pela população é fundamental, por ser a educação um importante determinante social. O clima escolar é a percepção do estudante sobre a instituição no tocante às relações interpessoais, infraestrutura, engajamento comunitário, cogestão, entre outros.Objetivo:caracterizar o clima escolar a partir da percepção dos estudantes, evidenciando as dimensões mais frágeis e as mais estabelecidas.Metodologia:Desenvolveu-se estudo transversal com 129 estudantes matriculados no ano de 2018 no segundo ano do ensino médio em escolas estaduais de Natal, Rio Grande do Norte, Brasil. Esses responderam a umquestionário para identificação do perfil socioeconômico e clima escolar. Foram calculadas as frequências e medidas de tendência central das variáveis.Resultados:Cerca de 80% dos estudantes concordaram gostar estar na escola ou sentir ter bons amigos nela; 70% afirmam ser boa a relação entre todos os atores da escola; 67,20% sentem que quem trabalha na escola gosta do que faz. Todavia, 40% dos alunos não sentem orgulho da escola, 32% concordaram que todos participam das tomadas de decisões importantes naescola e 53% disseram sentir-se seguros na escola.Conclusões:Conclui-se que Gestão & Transparência e a Infraestrutura são as dimensões mais frágeis do clima escolar, enquanto as melhor estabelecidas são Amizade, Relações Interpessoais, Acolhimento e Igualdade e Colaboração Mútua (AU).

Introduction:The population's perception of the meaning of school is fundamental, as education is an important social determinant. The School's climate is the students'perception of the institution with regard to interpersonal relationships, infrastructure, community engagement, co-management, among other factors.Objective:to characterize the school climate based on the students' perception, emphasizingboth the weakestand the most established dimensions.Methodology:across-sectional study was carried outwith 129 students which enrolled in the second year of high school in 2018 in state-runschools in Natal, Rio Grande do Norte,Brazil. Thesubjectsanswered a questionnaire to identify their socioeconomic profile and school climate. Frequencies and measures of central tendency were calculated.Results:About 80% of the students agreed that they like being at school or feel they have good friends at school; 70% say that the relationship among all school actorsis good; 67.20% feel that those who work at the school enjoy what they do. However, 40% of the students do not feel proud of their school, a mere 32% agreed that everyone participates in making important decisions at school, and only 53% statedthey feel safe at school.Conclusions:The results show that Management &Transparency and Infrastructure are the most fragile dimensions of the school climate, while the most established ones are Friendship, Interpersonal Relations, Welcoming and Equality and Mutual Collaboration (AU).

Introducción: La percepción de la población sobre el significado de la escuela es fundamental, ya que la educación es un importante determinante social.El clima escolar es la percepción del estudiante de la institución con respecto a las relaciones interpersonales, la infraestructura, el compromiso de la comunidad, la gestión conjunta, entre otros. Objetivo: caracterizar el clima escolar en función de la percepción de los estudiantes, mostrando las dimensiones más frágiles y las más estabelecidas.Metodología:across-sectional study was developed with 129 students enrolled in the year 2018 in the second year of high school in state schools in Natal, Rio Grande do Norte, Brasil. They answered a questionnaire to identify their socioeconomic profile and school climate. Frequencies and measures of central tendency of the variables were calculated. Resultados: Alrededor del 80% de los estudiantes coinciden en que les gusta estar en la escuela o sienten que tienen buenos amigos allí; el 70% dice que la relación entre todos los actores de la escuela es buena; el 67,20% siente que los que trabajan en la escuela disfrutan con lo que hacen. Sin embargo, el 40% de los alumnos no se sienten orgullosos de su escuela, el 32% está de acuerdo en que todos participan en la toma de decisiones importantes en la escuela y el 53% dice sentirse seguro en la escuela.Conclusiones: Se concluye que Gestión y Transparencia e Infraestructura son las dimensiones más débiles del clima escolar, mientras que las mejor establecidas son Amistad, Relaciones Interpersonales, Acogida e Igualdad y Colaboración Mutua (AU).

Percepções de alunos da rede pública de ensino de natal/rn sobre educação em saúde na escola / Perceptions of school students of the public network of Natal / RN about health education at school / Percepciones de los estudiantes de la escuela de la red pública de Natal / RN sobre la educaión em salud en la escuela

Introdução:O Programa Saúde na Escola (PSE) constitui-se em uma política intersetorialentre os Ministérios da Saúde e da Educação e prevê a realização de atividades técnico-assistenciais sob responsabilidade dos profissionais das Equipes de Saúde da Família (ESF), bem como atividades de educação popular em saúde.Objetivo:este estudo se propôs a identificar as atividades de educação em saúde realizadas nas escolas do ensino médio do município de Natal no estado do Rio Grande do Norte, bem como verificar as expectativas dos estudantes quanto ao papel dos profissionais de saúde e governantespara viabilizar uma melhoria de sua qualidade de vida.Metodologia:foi desenvolvido um estudo de avaliação com corte seccional e abordagem quantitativa com estudantes do segundo ano do ensino médio matriculados no ano de 2018. Esses estudantes responderam a um questionário para caracterização social e econômica afim de identificar as suas expectativas para melhoria da qualidade de vida e sobre atividades de educação em saúde realizadas na sua escola. A análise das respostas foi feita por meio de banco de dados no Excel para facilitar o cálculo das frequências absolutas e relativas das variáveis categóricas, bem como o cálculo da média e desvio-padrão das variáveis numéricas (idade, renda).Resultados:Dentre os principais resultados, destaca-se o baixo índice de ações voltadas à promoção da saúde nas escolas, sobretudo eventos do Programa de Saúde na Escola (PSE), bem como o desejo de que tanto os governantes quanto os profissionais de saúde exerçam de uma melhor forma o seu trabalho direcionado à comunidade.Conclusões:Concluiu-se, portanto, ser a ação do PSE na rede pública de Natal bastante falha, porquanto a maioria dos estudantes respondeunão reconhecer nenhuma ação exercida por este programa nassuas respectivas escolas (AU).

Introduction:The School Health Program (PSE) is an intersectoralpolicy between the Ministries of Health and Education and provides for technical assistance activities under the responsibility of the professionals of the Family Health Teams (ESF), as well as popular health education activities. Objective:This study aimed to identify health education activities carried out in high schools in the municipality of Natal in the state of Rio Grande do Norte, as well as to verify the expectations of students regarding the role of health professionals and government officials to enable an improvement in their quality of life. Methodology:an evaluation study was developed with a sectional cut and quantitative approach with second year high school students enrolled in 2018. These students answered a questionnaire for social andeconomic characterization in order to identify their expectations for improving the quality of life and on health education activities carried out in their school. The analysis of the answers was done through a database in Excel to facilitate the calculation of absolute and relative frequencies of the categorical variables, as well as the calculation of the mean and standard deviation of the numerical variables (age, income). Results:Among the main results, the low rate of actions aimed at promoting health in schools, especially events of the School Health Program (PSE), as well as the desire for both governments and health professionals to better exercise their work directed at the community. Conclusions:It was therefore concluded that the PSE action in the public Natal network was rather flawed, as most students responded by not recognising any action taken by this programme in their respective schools (AU).

Introducción: El Programa de Salud Escolar (PSE) es una política intersectorial entre los Ministerios de Salud y Educación y prevé actividades de asistencia técnica bajo la responsabilidad de los profesionales de los Equipos de Salud Familiar (ESF), así como actividades de educación sanitaria popular.Objetivo: este estudio tenía por objeto identificar las actividades de educación sanitaria realizadas en las escuelas secundarias del municipio de Natal, en elestado de Rio Grande do Norte, así como verificar las expectativas de los estudiantes en cuanto al papel de los profesionales de la salud y los funcionarios gubernamentales para permitir una mejora de su calidad de vida. Metodología: se desarrolló un estudio de evaluación con un corte seccional y un enfoque cuantitativo con estudiantes de segundo año de secundaria matriculados en 2018. Estos estudiantes respondieron a un cuestionario para la caracterización social y económica con el fin de identificar sus expectativas de mejora de la calidad de vida y sobre las actividades de educación sanitaria llevadas a cabo en su escuela. El análisis de las respuestas se realizó mediante una base de datos en Excel para facilitar el cálculo de las frecuencias absolutas yrelativas de las variables categóricas, así como el cálculo de la media y la desviación estándar de las variables numéricas (edad, ingresos). Resultados: Entre los principales resultados, el bajo índice de acciones dirigidas a promover la salud en las escuelas, especialmente los eventos del Programa de Salud Escolar (PSE), así como el deseo de que tanto los gobiernos como los profesionales de la salud ejerzan mejor su trabajo dirigido a la comunidad.Conclusiones: Por lo tanto, se llegó a la conclusión de que la acción del PSE en la red pública de Natalera bastante defectuosa, ya que la mayoría de los estudiantes respondieron no reconociendo ninguna acción realizada por este programa en sus respectivas escuelas (AU).

Immunogenicity of the CYD tetravalent dengue vaccine using an accelerated schedule: randomised phase II study in US adults.

BACKGROUND: The live attenuated tetravalent dengue vaccine (CYD-TDV) is licensed using a 0-, 6- and 12-month schedule in dengue-endemic areas. An effective shorter schedule may provide more rapid, optimal protection of targeted populations during vaccine campaigns in dengue-endemic countries. We compared immune responses to two schedules of CYD-TDV in a non-endemic population. We also evaluated the impact of yellow fever (YF) co-administration. METHODS: This phase II, open-label, multicentre study enrolled 390 healthy 18-45-year-olds in the USA with no prior exposure to dengue. Participants were randomised (4:4:4:1) to four treatment groups stratified by prior YF vaccine status: Group 1, CYD-TDV standard 0-6-12 months schedule; Group 2, CYD-TDV accelerated 0-2-6 months schedule; Group 3, CYD-TDV accelerated schedule with YF co-administered (dose 1); Group 4, YF vaccination only. Neutralising antibody geometric mean titres (GMTs) and percentages of seropositive participants (antibody titres ≥10 [1/dil]) were measured against each dengue serotype using a 50% plaque reduction neutralisation test. RESULTS: On D28 post-CYD-TDV dose 3, there were no marked differences in seropositivity rates and GMTs between Groups 1 and 2. In Groups 1 and 2 respectively, 73.4 and 82.4% were dengue seropositive for ≥3 serotypes, with 50.0 and 42.6% seropositive against all four serotypes. Flavivirus status (FV+ or FV-) at baseline did not markedly affect GMTs and seropositivity rates with either schedule. In Groups 1 and 2, GMTs measured 6 months after the third dose decreased against all serotypes, except for a small increase in GMT for serotype 4 in Group 1. In addition, dengue seropositivity remained above 70% for serotypes 2, 3 and 4 in Groups 1 and 2. Co-administration with YF did not affect antibody responses against dengue and YF or impact vaccine safety following completion of the compressed schedule, compared to dengue or YF vaccination alone. CONCLUSIONS: The live attenuated CYD-TDV vaccine given in a compressed schedule in a non-endemic setting can elicit similar antibody responses to the licensed CYD-TDV schedule. TRIAL REGISTRATION: This trial was registered on cinicaltrials.gov, NCT01488890 (December 8, 2011).

A randomized trial to assess safety and immunogenicity of alternative formulations of a quadrivalent meningococcal (A, C, Y, and W-135) tetanus protein conjugate vaccine in toddlers.

BACKGROUND: Neisseria meningitidis is a leading cause of meningitis and septicemia globally. Recent shifts in serogroup dominance in some settings highlight the desirability of polysaccharide-conjugate vaccines with broader meningococcal coverage than serogroup C vaccines in widespread use. METHODS: We assessed the safety and immunogenicity of a single dose of meningococcal quadrivalent (A, C, W-135, Y) tetanus conjugate vaccine (TetraMen-T), administered at 1 year of age. A total of 378 children were randomized to 1 of 6 groups--5 received alternative formulations of TetraMen-T, the sixth licensed adjuvanted serogroup C conjugate vaccine (Neisvac-C). Solicited adverse event reports were collected from day 0 to 7 after vaccination and unsolicited and serious adverse event reports throughout study participation. Immunogenicity was assessed by serum bactericidal assays containing either a human (hSBA) or baby rabbit (rSBA) complement source before and 1 month after immunization. RESULTS: All vaccine formulations were safe and well tolerated. Using the various measures of immunogenicity, no consistent relationships were observed between the dose of either polysaccharide or carrier and serogroup-specific response for any one antigen. The highest-dose vaccine provided optimal coverage for all 4 serogroups, with the percentage of recipients achieving hSBA titers ≥ 8 against each as follows: A, 92%; C, 96%; W-135, 71%; Y, 82% (corresponding proportions with rSBAs titers >8 all exceeded 90%). The investigational vaccines were less immunogenic against the serogroup C capsular polysaccharide than the licensed comparator. CONCLUSIONS: Studies are ongoing that will help to identify optimal scheduling of quadrivalent meningococcal conjugate vaccines, to facilitate their inclusion into national immunization programs seeking extended serogroup coverage against meningococci.

Immune memory in children previously vaccinated with an experimental quadrivalent meningococcal polysaccharide diphtheria toxoid conjugate vaccine.

BACKGROUND: In a previous study, a meningococcal diphtheria toxoid conjugate vaccine (MCV-4) triggered robust bactericidal antibody responses against serogroups A, C, Y, and W-135 in 2- to 10-year-old children. A subset of participants, 2 to 3 years of age at the initial vaccination, was evaluated for persistence of antibody, immune memory, and antibody avidity. METHODS: Participants were healthy children vaccinated 23 to 36 months earlier with MCV-4 (primed) or newly recruited meningococcal vaccine-naive 4-year-olds. Participants in both groups were alternately allocated to provide sera 8 or 28 days after administration of one tenth of the recommended dose of a meningococcal polysaccharide vaccine (PSV-4). Immune responses were assessed in sera obtained at baseline and either 8 or 28 days after reduced-dose PSV-4 administration. Safety was monitored. RESULTS: Before PSV-4 challenge, serum bactericidal antibody geometric mean titers (SBA GMTs) were higher for all 4 serogroups in the MCV-4-primed group than in the vaccine-naive group. SBA GMTs, geometric mean concentrations of immunoglobulin G (IgG) and geometric mean avidity indices for all 4 serogroups were significantly higher among MCV-4-primed versus vaccine-naive participants in the cohorts evaluated at 8 or 28 days after PSV-4 challenge. Adverse events were generally mild, self-limited, and comparable in all groups of children. CONCLUSIONS: Persistence of bactericidal antibody was seen for 23 to 36 months after a primary dose of MCV-4 in young children. Booster responses and avidity maturation were evident after a challenge with reduced-dose polysaccharide vaccine.

Antibody responses to meningococcal (groups A, C, Y and W135) polysaccharide diphtheria toxoid conjugate vaccine in children who previously received meningococcal C conjugate vaccine.

A randomised, modified, double-blind trial was conducted in children 2 to < 5 years of age to evaluate immunogenicity and reactogenicity of a meningococcal (serogroups A, C, Y, W135) diphtheria toxoid conjugate vaccine (MCV-4) in healthy children previously vaccinated with a monovalent meningococcal C conjugate vaccine. Participants received one dose of either MCV-4 or Haemophilus influenzae type b vaccine (Hib vaccine, control group). Serum bactericidal antibodies (SBA) were determined in sera obtained before and approximately 28 days following vaccination. MCV-4 was highly immunogenic for serogroups A, C, Y and W135, the response to serogroup C being consistent with a booster response in participants primed with monovalent C conjugate vaccine. No major between-group differences in solicited local and systemic reactions or adverse events (AEs).

Safety, immunogenicity, and immune memory of a novel meningococcal (groups A, C, Y, and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV-4) in healthy adolescents.

OBJECTIVE: A meningococcal (groups A, C, Y, and W-135) polysaccharide diphtheria toxoid conjugate vaccine (MCV-4; Menactra; Sanofi Pasteur Inc, Swiftwater, Pa) was developed to improve the profile of currently licensed products. The objective of this study was to compare the tolerability, immunogenicity, and immune memory of MCV-4 with those of a quadrivalent polysaccharide vaccine (PSV-4; Menomune A/C/Y/W-135; Sanofi Pasteur Inc). DESIGN, SETTING, PARTICIPANTS: A randomized, double-blind trial was performed at 11 clinical centers in the United States. The vaccine MCV-4 or PSV-4 was administered to 881 healthy 11- to 18-year-olds. Sera were collected prevaccination and 28 days postvaccination. Three-year follow-up and booster vaccination with MCV-4 were performed in a participant subset from each group and a control group. MAIN OUTCOME MEASURES: Proportion of participants with a 4-fold or greater increase in serum bactericidal antibody against each serogroup 28 days after initial vaccination, geometric mean serum bactericidal antibody titers, and safety assessments. RESULTS: Both vaccines were well tolerated; most reactions were mild. More MCV-4 recipients reported solicited local reactions (68.9%) than PSV-4 recipients (30.2%). Both MCV-4 and PSV-4 were highly immunogenic; similar proportions of participants had 4-fold or greater increases in serum bactericidal antibody (range, 80.1%-96.7%) to the 4 serogroups. Three-year follow-up showed persistence of serum bactericidal antibody and booster responses to MCV-4 consistent with immune memory in participants previously vaccinated with MCV-4, but not in those who had previously received PSV-4. CONCLUSIONS: The vaccine MCV-4 was well tolerated and highly immunogenic. Persistence of bactericidal activity with MCV-4, but not PSV-4, was evident 3 years after the initial immunization. Booster response was demonstrated after a second vaccination with MCV-4.

Comparative trial of the safety and immunogenicity of quadrivalent (A, C, Y, W-135) meningococcal polysaccharide-diphtheria conjugate vaccine versus quadrivalent polysaccharide vaccine in two- to ten-year-old children.

BACKGROUND: A quadrivalent meningococcal diphtheria conjugate vaccine (MCV-4) has been developed to provide T-cell dependent immune responses against 4 major disease-causing serogroups (A, C, Y, W-135). METHODS: In a comparative, randomized, modified double blind, controlled study in healthy 2- to 10-year-old U.S. children, safety and immunogenicity profiles of MCV-4 (n = 696) were compared with those of a licensed quadrivalent polysaccharide vaccine, Menomune A/C/Y/W-135 (PSV-4, n = 702). Vaccine-related adverse reactions were assessed for 28-day and 6-month follow-up periods. Serum bactericidal activity (SBA) was assayed in prevaccination, day 28 and 6-month postvaccination sera samples. RESULTS: Both vaccines were well-tolerated, with no vaccine-related serious adverse events and similar rates of mostly mild local and systemic reactions. Functional antibody (SBA) seroconversion percentages were significantly higher for all 4 serogroups in the MCV-4 group. The SBA geometric mean titers against serogroups A, C, Y and W-135 with MCV-4 were 1700, 354, 637 and 750, respectively, compared with PSV-4 (893, 231, 408 and 426) 28 days postvaccination (P < 0.001 for all comparisons). This significant difference persisted through 6 months. CONCLUSIONS: In 2- to 10-year-old children MCV-4 had a safety profile similar to that of PSV-4 and elicited significantly higher and more persistent serum bactericidal antibody responses against meningococcal serogroups A, C, Y and W-135 than did the licensed polysaccharide vaccine.

Safety and immunogenicity of a meningococcal (Groups A, C, Y, W-135) polysaccharide diphtheria toxoid conjugate vaccine in healthy children aged 2 to 10 years in Chile.

Immune responses to meningococcal conjugate (Menactra; MCV-4) and plain polysaccharide (Menomune-A/C/Y/W-135; PSV-4) vaccines against serogroups A, C, Y, and W-135 were assessed in 220 of 1037 Chilean children aged 2 to 10 years participating in a comparative safety trial. Both vaccines were generally well tolerated. Geometric mean serum bactericidal antibody (SBA) titers 28 days postvaccination were comparable in both groups for all four serogroups. Seroconversion was evident in > 97% of MCV-4 and > 90% of PSV-4 vaccinees who tested seronegative at baseline. Menactra safely induced broad and robust immune responses against serogroups A, C, Y and W-135 in this population.

Dosage escalation, safety and immunogenicity study of four dosages of a tetravalent meninogococcal polysaccharide diphtheria toxoid conjugate vaccine in infants.

BACKGROUND: Young children have the highest incidence of meningococcal infection. Approximately 50% of disease in United States children less than 2 years of age is caused by serogroups C and Y. In the developing world, serogroups A and W-135 cause outbreaks and epidemics of infection. METHODS: Three groups of 30 infants were enrolled. The first group of infants was given 3 doses of a quadrivalent (group A, C, Y, W-135) polysaccharide meningococcal vaccine conjugated to diphtheria toxoid (MCV-4) at a dosage of 1 microg of each serogroup polysaccharide. The second group of infants was given MCV-4 at a dosage of 4 microg, and the last group of children received a 10-microg dosage. Vaccinations were given at 2, 4 and 6 months of age.A subset of these children was vaccinated at 15 to 18 months of age with licensed meningococcal polysaccharide (A, C, Y, W-135) vaccine. Serum bactericidal antibody (SBA) titers were measured with baby rabbit complement. RESULTS: The proportion of infants with local reactions increased significantly with increasing dosages after Injection 1 and 3. Approximately 1 month after completion of the primary series, the proportion of infants with an SBA titer > or = 1/8 ranged from 54 to 92%, depending on the serogroup and dose of polysaccharide contained in the vaccine. The SBA geometric mean titer varied from 17.4 to 101.6. There was no statistically significant difference between the SBA responses among the 3 dosage groups. After vaccination with polysaccharide vaccine at 15 to 18 months of age, mean fold increases in SBA of 4.9 to 170.3 were observed, suggesting an anamnestic response. CONCLUSIONS: MCV-4 appears to have a reactogenicity profile acceptable to parents and health care providers. It was only modestly immunogenic in infants, but it appeared to prime the immune system of the majority of infants given three doses in infancy. There is no statistically significant immunologic advantage conferred by increasing the dosage beyond 4 microg/ml, and local reactions are more frequent after the 10-microg/ml dosage.

Assignment of Neisseria meningitidis serogroups A, C, W135, and Y anticapsular total immunoglobulin G (IgG), IgG1, and IgG2 concentrations to reference sera.

Meningococcal serogroup-specific immunoglobulin G (IgG), IgG1, and IgG2 concentrations were assigned to three reference sera, CDC 1992, 89-SF, and 96/562, for meningococcal serogroups A, C, Y, and W135 via the method of cross standardization. The sum of the serogroup-specific IgG1 and IgG2 concentrations determined for the four meningococcal serogroups showed good agreement with the serogroup-specific IgG either determined here or as previously represented. Following the assignment of meningococcal serogroup-specific IgG1 and IgG2 concentration to these reference sera, a meningococcal serogroup-specific IgG1 and IgG2 enzyme-linked immunosorbent assay protocol was developed. The serogroup A and C specific subclass distribution of a panel of adult sera collected following vaccination with any combination of meningococcal serogroup C conjugate, bivalent, or tetravalent polysaccharide vaccines was determined. For the determination of serogroup W135 and Y specific subclass distribution, an adolescent panel 28 days following a single dose of either tetravalent polysaccharide or conjugate vaccine was used. The sum of the serogroup-specific IgG1 and IgG2 showed strong correlation with the serogroup-specific total IgG determined. The assignment here of IgG1 and IgG2 subclasses to these reference sera will allow more detailed evaluation of meningococcal conjugate and polysaccharide vaccines.

Immunogenicity and immunological priming of the serogroup a portion of a bivalent meningococcal A/C conjugate vaccine in 2-year-old children.

Two-year-old children were vaccinated with 1 dose of meningococcal A/C conjugate (MACC) or meningococcal A/C polysaccharide (MACP) vaccine. Meningococcal serogroup A (MenA)-specific IgG geometric mean avidity indices (GMAIs) increased 1 month after vaccination with MACC (GMAI, 210; 95% confidence interval [CI], 140-300) and MACP (GMAI, 190; 95% CI, 120-310). One year after vaccination, the GMAI of the MACP-vaccinated cohort decreased to 130 (95%, CI 100-170), but a constant GMAI was maintained in the MACC-vaccinated cohort (210; 95% CI, 140-300), despite declining MenA-specific IgG antibody levels.

Safety, reactogenicity, and immunogenicity of a tetravalent meningococcal polysaccharide-diphtheria toxoid conjugate vaccine given to healthy adults.

Healthy adults, 18-55 years old, were immunized once with a tetravalent (serogroups A, C, Y, and W-135) meningococcal vaccine conjugated to diphtheria toxoid at 1 of 3 doses and were monitored for safety, reactogenicity, and immunogenicity. No immediate reactions were observed. Only 1 of 89 subjects reported fever; only 1 reported any severe reactogenicity (local pain/soreness, chills, arthralgia, anorexia, and malaise). For each serogroup and in each dose group, the geometric mean serum bactericidal antibody (SBA) titer and immunoglobulin G concentration increased after immunization. In the 4- and 10-microg-dose groups, all subjects had SBA titers >/=8 against serogroups A and C, and 89% and 93% of subjects had SBA titers >/=8 against serogroups Y and W-135, respectively. The A, C, Y, and W-135 Neisseria meningitidis-diphtheria toxoid conjugate vaccine, when given to healthy adults as a single intramuscular injection of 1, 4, or 10 microg/serogroup, is acceptably tolerated and immunogenic and deserves further development.

Dose escalation, safety and immunogenicity study of a tetravalent meninogococcal polysaccharide diphtheria conjugate vaccine in toddlers.

Two injections of tetravalent (Groups A, C, Y and W-135) meningococcal polysaccharide vaccine conjugated to diphtheria were given to 30 toddlers at dosages of 1, 4 and 10 microg/ml polysaccharide of each serogroup. Reactogenicity was acceptable at all dosages. The 4-microg/ml dose appears to be immunologically optimal.