Effect of Executive Function on Health-Related Quality of Life in Children with Chronic Kidney Disease.

Introduction: As the highest function in the brain that regulates our daily activity, executive dysfunction might affect someone's health-related quality of life (HRQoL), especially in those with chronic diseases, including chronic kidney disease (CKD). Neurocognitive functions, including intelligence quotient (IQ) and executive function can be affected through various mechanisms in CKD. However, there was still no specific study regarding how IQ and executive function might affect HRQoL in children with CKD. Purpose: To assess Executive Function's impact on HRQoL and to find association between treatment modalities and CKD stages with HRQoL in children with CKD. Methods: A cross sectional study was conducted at Pediatric Nephrology Clinic at Hasan Sadikin General Hospital, Bandung, Indonesia from September 2022 to April 2023. We included 38 children whose age range were 6-16 years 11 months old with CKD stage III - V. Assessment tools used were: BRIEF questionnaire for executive function; WISC III tool for IQ; PedsQLTM questionnaire generic module for HRQoL. Data was analyzed using SPSS ver. 26.0. Results: Total number of samples was 38. Complete examinations were done on 30 patients. Eight other patients did not undergo the IQ test. There was a negative correlation between executive function components scores (GEC, BRI, MI) with HRQoL scores on parents' proxy in all domains. We found no correlation between HRQoL and IQ scores, but we found a correlation between IQ and CKD stage. There was a significant difference in HRQoL from the children's perspective among the three modalities; children who underwent conservative treatment were having the best HRQoL scores. Conclusion: Interventions to improve executive function of children with CKD should be done to improve their HRQoL in the future. Early diagnosis and treatment of CKD should be done at the earliest to improve neurocognitive function and HRQoL.

Correlation Between Adolescent Mental Health and Sleep Quality: A Study in Indonesian Rural Areas During the COVID-19 Pandemic.

Objective: The study aims to analyze the correlation between sleep quality and adolescent mental health in rural areas during the Coronavirus Disease 2019 (COVID-19) pandemic. Material and Methods: A cross-sectional study was conducted in Bandung rural area in February 2023. The subjects were adolescents aged 12-15 years who attended high school in Sagaracipta Village. To assess mental health, the Strength and Difficulties Questionnaire (SDQ) was used. Meanwhile, sleep quality was assessed using the Pittsburgh Sleep Quality Index (PSQI) questionnaire. The questionnaires were distributed and then filled in directly by the participants under close supervision. The relationship between mental problems and sleep quality was analyzed with the Spearman Rank correlation. The confidence range employed was 95%, while p< 0.05 was considered statistically significant. Results: The results showed that at two junior high schools in Sagaracipta Village, 70.6% of the 109 subjects had poor sleep quality. Among the subjects, a significant number exhibited abnormal scores on various subscales. Specifically, 24 subjects (22%) showed abnormalities in the emotional subscales, 18 (16.5%) in conduct, 5 (4.6%) in hyperactivity, 15 (13.8%) in problems with peers, 26 (23.9%) in total difficulty, but there were no abnormal subjects on the pro-social sunscale. Based on the Rank Spearman correlation test, there was a statistically significant correlation between sleep quality and the emotional, behavioral, hyperactivity, and overall difficulties subscales, with coefficients of 0.247; 0.258; 0.22; and 0.310 as well as p-values of 0.010; 0.007; 0.021; and 0.001 respectively. Conclusion: During the COVID-19 pandemic, there was a correlation between mental health and sleep quality among adolescents in rural area.

Immunogenicity and safety of Quadrivalent Influenza HA vaccine compared with Trivalent Influenza HA vaccine and evaluation of Quadrivalent Influenza HA vaccine batch-to-batch consistency in Indonesian children and adults.

One of the newest strategies developed by the Global Influenza Strategy has been to broaden the composition of the current influenza vaccine formulations from trivalent products to quadrivalent products. This study aimed to assess the immunogenicity and safety of Quadrivalent Influenza HA vaccine (QIV) compared with Trivalent Influenza HA vaccine (TIV) and to evaluate three consecutive batches of QIV equivalence in Indonesian children and adults. This was an experimental, randomized, double blind, four arm parallel group bridging study involving unprimed healthy children and adults aged 9-40 years. A total of 540 subjects were enrolled in this study and randomized into four arm groups. Each subject received one dose of TIV or QIV with three different batch codes. Serology tests were performed at baseline and 28 days after vaccination. Hemagglutination inhibition (HI) antibody titers were analyzed for Geometric Mean Titer (GMT), seroprotection, and seroconversion rates. Solicited, unsolicited, and serious adverse events were observed up to 28 days after vaccination. A total of 537 subjects completed the study per protocol and were analyzed for immunogenicity criteria. All randomized subjects were analyzed for safety criteria. The percentage of the subjects with anti-HI titer ≥1:40 28 days after QIV vaccination was 99.5% for A/H1N1; 99.5% for A/H3N2; 93.1% for B/Texas, and 99.0% for B/Phuket. The seroprotection, GMT, and seroconversion rates of QIV were not significantly different from those of TIV for the common vaccine strains (p > 0.01) and were significantly different from those of TIV for the added B/Phuket strains (p < 0.01). Most solicited injection-site and systemic reactions with either vaccine were mild to moderate and resolved within a few days. Antibody response to QIV were equivalence among vaccine batches and comparable between age groups for each of the 4 strains. QIV was immunogenic and well-tolerated and had immunogenicity and safety profiles compared with TIV for all common strains. The immunogenicity of the three batches of QIV was equivalent for the four strains. Trial registration. Clinical Trial registration: NCT03336593.

Factors Affecting the Developmental Status of Children Aged 6 Months to 2 Years in Urban and Rural Areas.

The first two years of life, including the period from conception to 2 years of age, are very important for a child's growth and development. This study sought to describe the developmental status and the environmental factors that influence it in children aged 6 months to 2 years in urban and rural areas. The research sites were purposively selected: specific health centres in the city of Bandung and West Bandung district were chosen and the study was conducted from November to December 2022. A cross-sectional study was conducted with healthy children aged 6 months to 2 years and their parents, who agreed to participate in the study. Researchers performed developmental tests using the Developmental Pre-screening Questionnaire with classifications for normal developmental test results and developmental delays. During the study, 346 children met the inclusion criteria, resulting in a sample of 164 (47.4%) boys and 182 (52.6%) girls. There were no significant differences among children with developmental delays in urban and rural areas. The factors that influence the possibility of developmental delays in the two research areas were the child's age, exposure to screen time, stimulation, nutritional status, and the use of the mother-child handbook.

Correlation between anthropometric measurements of height and arm span in Indonesian children aged 7-12 years: a cross-sectional study.

BACKGROUND: Height is an anthropometric measurement that serves as the most constant indicator of growth. In certain circumstances, arm span can be used as an alternative to height measurements. This study aims to analyze the correlation between anthropometric measurements of height and arm span in children aged 7-12 years. METHODS: A cross-sectional study was carried out from September to December 2019 in six elementary schools in Bandung. Children aged 7-12 years were recruited with a multistage cluster random sampling method. Children with scoliosis, contractures, and stunting were excluded from the study. Height and arm span were measured by two pediatricians. RESULTS: A total of 1,114 children, comprising 596 boys and 518 girls, fulfilled the inclusion criteria. The ratio of height to arm span was 0.98-1.01. The regression equation used to predict height through measurement of arm span in male subjects was Height = 21.8623 + 0.7634 x Arm span (cm) + 0.0791 x age (month); R2 = 94%; standard error of estimate (SEE): 2.66 and that in female subjects was Height = 21.2395 + 0.7779 x Arm span (cm) + 0.0701 x age (month); R2 = 95.4%; SEE: 2.39. The predicted height and the average actual height were not significantly different. There is a strong correlation between height and arm span in children aged 7-12 years. CONCLUSIONS: Arm span can be used to predict the actual height of children aged 7-12 years and as an alternative measurement for growth.

Comparison of Immunogenicity and Safety of Diphtheria-Tetanus-Pertussis-Hepatitis B-Haemophilus influenza B (Bio Farma) with Pentabio® Vaccine Primed with Recombinant Hepatitis B at Birth (Using Different Source of Hepatitis B) in Indonesian Infants.

Satisfying the needs of the national immunization program requires maintaining diphtheria-tetanus-pertussis (DTP)-hepatitis B (HB)-Haemophilus influenza B (Hib) production. Therefore, new hepatitis B sources are needed. This study aimed to evaluate the immunogenicity of the DTP-HB-Hib vaccine (Bio Farma) that used a different source of hepatitis B. A prospective randomized, double-blind, bridging study was conducted. Subjects were divided into two groups with different batch numbers. Healthy infants 6-11 weeks of age at enrollment were immunized with three doses of the DTP-HB-Hib vaccine after a birth dose of hepatitis B vaccine. Blood samples were obtained prior to vaccination and 28 days after the third dose. Adverse events were recorded until 28 days after each dose. Of the 220 subjects, 205 (93.2%) completed the study protocol. The proportion of infants with anti-diphtheria and anti-tetanus titers ≥ 0.01 IU/mL was 100%, with anti-HBsAg titers ≥ 10 mIU/mL was 100%, and with Polyribosylribitol Phosphate-Tetanus Conjugate (PRP-TT) titers > 0.15 µg/mL was 96.1%. The pertussis response rate was 84.9%. No serious adverse events related to the study vaccine occurred. The three-dose DTP-HB-Hib vaccine (Bio Farma) is immunogenic, well tolerated, and suitable to replace licensed-equivalent vaccines.

Psychometric Properties of the Suicidal Ideation Scale in the Indonesian Language.

INTRODUCTION: Suicide is one of the leading cause of mortality among adolescents and young adults, especially in low to middle-income countries. Research found that screening for suicidal ideation in non-clinical populations such as schools or communities is an important step toward preventing suicide. Despite so, not all screening tools have the capabilities to accurately detect suicidal ideation among adolescents and young adults in non-clinical populations. The Suicidal Ideation Scale (SIS) is one of the most used questionnaires to measure suicidal thoughts in non-clinical populations. This study aims to investigate the psychometric properties of SIS among adolescents and young adults in Indonesia, especially in non-clinical populations. METHODS: After a series of language and cultural adaptations, 1254 senior high school and university students completed the Indonesian version of SIS using 3 standard questionnaires, namely Patient Health Questionnaire-9/PHQ-9, Beck Depression Inventory-II/BDI-II, and Children's Depression Inventory/CDI. The SIS content validity, internal consistency, test-retest reliability and concurrent, as well as internal structure validity, were investigated using content validity index (CVI), Cronbach's Alpha, Pearson product-moment correlation, and confirmatory factor analysis (CFA), respectively. RESULTS: The result showed that SIS has good to excellent internal consistency and test-retest reliability. Based on the validity indicators, it has satisfactory content and convergent validity, and further support the one-factor and 2-factor model for factorial validity. Both one-factor and 2 factor model are suitable to use in non-clinical settings. CONCLUSIONS: SIS is a valid and reliable tool for suicide ideation screening in adolescents and young adults in non-clinical populations. This validated questionnaire can be used in the early detection of suicidal ideation among adolescents and young adults in non-clinical populations, thus contributing to developing strategies and policies to prevent suicide among Indonesian adolescents and young adults at group and institutional levels.

A phase III, observer-blind, randomized, placebo-controlled study of the efficacy, safety, and immunogenicity of SARS-CoV-2 inactivated vaccine in healthy adults aged 18-59 years: An interim analysis in Indonesia.

BACKGROUND: The WHO declared COVID-19 a pandemic on March 11th, 2020. This serious outbreak and the precipitously increasing numbers of deaths worldwide necessitated the urgent need to develop an effective severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine. The development of COVID-19 vaccines has moved quickly. In this study, we assessed the efficacy, safety, and immunogenicity of an inactivated (SARS-CoV-2) vaccine. METHODS: We conducted a randomized, double-blind, placebo-controlled trial to evaluate the efficacy, immunogenicity, and safety of an inactivated SARS-CoV-2 vaccine and its lot-to-lot consistency. A total of 1620 healthy adults aged 18-59 years were randomly assigned to receive 2 injections of the trial vaccine or placebo on a day 0 and 14 schedule. This article was based on an interim report completed within 3 months following the last dose of study vaccine. The interim analysis includes safety and immunogenicity data for 540 participants in the immunogenicity subset and an efficacy analysis of the 1620 subjects. For the safety evaluation, solicited and unsolicited adverse events were collected after the first and second vaccination within 14 and 28 days, respectively. Blood samples were collected for an antibody assay before and 14 days following the second dose. RESULTS: Most of the adverse reactions were in the solicited category and were mild in severity. Pain at the injection site was the most frequently reported symptom. Antibody IgG titer determined by enzyme-linked immunosorbent assay was 97.48% for the seroconversion rate. Using a neutralization assay, the seroconversion rate was 87.15%. The efficacy in preventing symptomatic confirmed cases of COVID-19 occurring at least 14 days after the second dose of vaccine using an incidence rate was 65.30%. CONCLUSIONS: From the 3-month interim analysis, the vaccine exhibited a 65.30% efficacy at preventing COVID-19 illness with favorable safety and immunogenicity profiles.

Height Prediction Using the Knee Height Measurement Among Indonesian Children.

BACKGROUND: Height is essential for assessing growth and nutrition in children. Assessing height with appropriate measurement is important, although in certain physically disabled and hospitalized children direct height measurement is almost not possible. In these situations, segmental measurements can be used as proxy height. Knee height (KH) has been determined as the most reliable surrogate. OBJECTIVE: This study aimed to establish a height-predicted equation using KH for use in both community and clinical practices. METHODS: This was a cross-sectional study design that collected data from 1114 healthy children (596 boys and 518 girls) aged 7 to 12 years to develop the equations for predicting height from KH. A multiple linear regression analysis was used to develop the equations. RESULTS: Two equations were established to predict height using KH: (1) for boys H = 29.895 + (0.081 × age [months] + (2.267 × KH)) and (2) for girls H = 26.297 + (0.110 × age [months] + (2.278 × KH)). The very high correlation between KH and actual height indicates a very strong agreement. CONCLUSIONS: Knee height can be used for prediction equations for height with a very good predictive power. The age variable using the month unit generates a more accurate equation.

Temporal association between serious bleeding and immunization: vitamin K deficiency as main causative factor.

BACKGROUND: Bleeding as an adverse event following immunization (AEFI) that is rarely reported in children, although it can be a parental concern. Bleeding episodes ranging in severity from mild to severe and defined as any external and/or internal bleeding can be caused by acquired or hereditary disorders. This study analyzes whether bleeding episodes in children that were recorded as AEFIs are causally associated with immunization and elaborates their etiology. METHODS: A cross-sectional study of 388 AEFI cases in children from West Java Provincial Committee in Indonesia confirmed by case findings from 2000 until 2017. RESULTS: Of the total number of cases studied, 55 (14%) involved children aged 5 days to 12 years who presented with bleeding and were referred to a provincial hospital. Analysis revealed that 32 cases were most likely caused by acquired prothrombin complex deficiency (APCD) and 30 of these APCD cases were strongly suspected to be manifestations of vitamin K deficiency bleeding (VKDB). All VKDB subjects were aged 5 days to 3 months without a history of administration of prophylactic vitamin K. When a World Health Organization classification was used, most bleeding cases in this study became coincidental events with a temporal association with immunization. A causality assessment suggested that these cases were causally unrelated. CONCLUSION: Most cases of bleeding reported as an AEFI were found to be VKDB, which is considered a coincidental event following immunization with a temporal association, and an unrelated category based on the results of a causality assessment. Vitamin K should be administered to all newborns as a prophylactic and AEFI surveillance should be improved based on the low numbers of AEFI reported in Indonesia.

Immunogenicity and safety profile of a primary dose of bivalent oral polio vaccine given simultaneously with DTwP-Hb-Hib and inactivated poliovirus vaccine at the 4th visit in Indonesian infants.

In this study, we aimed to evaluate the immunological protectivity of infants following four doses of bivalent oral polio vaccine (bOPV; Bio Farma), which were given simultaneously with DTwP-Hb-Hib (Pentabio®), along with one dose of inactivated poliovirus vaccine (IPV) at the fourth visit. A total of 143 newborn infants who fulfilled the inclusion criteria were enrolled and completed the study. Subjects received the first dose of bOPV at birth. On days 60, 90 and 120, bOPV was given simultaneously with Pentabio®. On day 120, one dose of IPV was also administered. Serum samples for serology analysis were collected before the first dose of bOPV (at day 0), before the second dose of bOPV (at day 60) and 30 days after the last dose of bOPV. In addition, the intensity, duration and relationship of each adverse event to the trial vaccines were assessed. Seroprotection rates after the fourth dose of bOPV were 100%, 91.6% and 99.3% for poliovirus P1, P2 and P3, respectively. Seroconversion rates after the fourth dose of bOPV were 100.0%, 93.3% and 100% for poliovirus P1, P2 and P3, respectively. There were no severe adverse events, and systemic reactions were generally mild during the 1-28 day post-vaccination period. Collectively, our findings indicate that bOPV given simultaneously with Pentabio® and one dose of IPV at the 4th visit was immunogenic and well tolerated.

Immunogenicity and safety of Quadrivalent Influenza HA vaccine in Indonesian children: An open-labeled, bridging, clinical study.

BACKGROUND: Influenza B (Yamagata/Victoria lineage) can cause severe forms of respiratory infection among the pediatric population as well as influenza A strains (H3N2/H1N1). Vaccination against all four strains is required to prevent infection and severe outcome. This study is the first study to assess the immunogenicity of Quadrivalent Influenza HA vaccine (QIV) and ascertain safety among children in Indonesia. METHODS: This is an open labeled, single arm, bridging clinical study involving unprimed healthy children 6-35 months of age (Group I) and 3-8 years of age (Group II). Subjects on both groups receiving two doses of QIV with a 28 days interval. Serology tests were performed on baseline and 28 days post-vaccination. Hemagglutination inhibition antibody titers were analyzed for Geometric Mean Titer (GMT), seroprotection, and seroconversion rates. Solicited reactions, unsolicited adverse events, and serious adverse events were observed up to 28 days post-vaccination. RESULTS: Out of 270 subjects enrolled, 269 subjects completed the study. Immunogenicity analysis were evaluated on 254 subjects. Seroprotection rates were ≥85% for all vaccine strains in both groups. Seroconversion of more than 4 folds for all strains occurred in both groups post-vaccination. In Group I, the increase of GMT for A/H1N1, A/H3N2, B/Texas, and B/Phuket was 12.5, 14.5, 8.2, and 6.4 folds, respectively. In Group II the increase of GMT for A/H1N1, A/H3N2, B/Texas, and B/Phuket was 14, 17, 10, and 8 folds, respectively. The majority of local adverse events (AEs) after the first and second immunizations were immediate injection-site pain (10.4% and 12.6%). The majority of systemic AEs after the first and second immunizations were delayed unsolicited AEs (14.8% and 14.9%). No vaccine-related serious adverse events or deaths were reported. CONCLUSION: The investigational QIV was immunogenic with an acceptable safety profile in children 6 months to 8 years of age. CLINICAL TRIAL REGISTRATION: NCT03336593.

Pneumococcal carriage, density, and co-colonization dynamics: A longitudinal study in Indonesian infants.

OBJECTIVES: Nasopharyngeal carriage of Streptococcus pneumoniae underpins disease development and transmission. This study was performed to examine pneumococcal carriage dynamics, including density and multiple serotype carriage, in Indonesian infants during the first year of life. METHODS: Two hundred healthy infants were enrolled at 2 months of age. Eight nasopharyngeal swabs were collected from enrolment until 12 months of age. Pneumococci were detected using quantitative PCR and serotyped by microarray. Regression models assessed factors influencing pneumococcal carriage and density. RESULTS: Eighty-five percent of infants carried pneumococci at least once during the study. The median age at first acquisition was 129 days (interquartile range 41-216 days). The median duration of carriage was longer for the first pneumococcal acquisition compared with subsequent acquisitions (151 days vs. 95 days, p<0.0001). Of the 166 infants who carried pneumococci during the study, the majority (63.9%) carried a single pneumococcal serotype at a time. Pneumococcal carriage density was higher when upper respiratory tract infection symptoms were present, lower during antibiotic usage, decreased with age, and tended to decrease over time during a carriage episode. CONCLUSIONS: The majority of Indonesian infants carry pneumococcus at least once during the first year of life. Pneumococcal carriage is a dynamic process, with pneumococcal density varying during a carriage episode.

DTwP-HB-Hib: antibody persistence after a primary series, immune response and safety after a booster dose in children 18-24 months old.

BACKGROUND: The new combination of DTwP-HB-Hib vaccines has been developed in Indonesia following World Health Organization (WHO) recommendation and integrated into national immunization program. The aims of the study were to measure 1) antibody persistence 12-18 months after a primary series, 2) immune response and safety after a booster dose of DTwP-HB-Hib. METHODS: This was a multi-center, open-labeled, prospective, interventional study. Subjects who had received complete primary dose of DTwP-HB-Hib vaccine from the previous phase III trial were recruited in this trial. Subjects were given one dose of DTwP-HB-Hib (Pentabio®) booster at age 18-24 months old. Diphtheria, tetanus, pertussis, hepatitis B, Hemophilus influenza type B antibodies were measured before and after booster to determine antibody persistence and immune response. Vaccine adverse events were assessed immediately and monitored until 28 days after the booster recorded with parent's diary cards. RESULTS: There were 396 subjects who completed the study. Increased proportion of seroprotected subjects from pre-booster to post-booster were noted in all vaccine antigens: 74.5 to 99.7% for diphtheria; 100 to 100% for tetanus; 40.4 to 95.5% for pertussis; 90.2 to 99.5% for hepatitis B; and 97.7 to 100% for Hib. Common systemic adverse events (AEs) were irritability (23.7-25%) and fever (39.9-45.2%). Local AEs such as redness, swelling, and induration were significantly less common in the thigh group (7.7, 11.3, and 7.1%) than in the deltoid group (28.9, 30.7, and 25%) (P < 0.001). Most AEs were mild and resolved spontaneously within three-day follow-up period. CONCLUSIONS: Booster of DTwP-HB-Hib vaccine at age 18-24 months is required to achieve and maintain optimal protective antibody. The vaccine is safe and immunogenic to be used for booster vaccination. TRIAL REGISTRATION: NCT02095314 (retrospectively registered, March 24, 2014).

Carriage of Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Staphylococcus aureus in Indonesian children: A cross-sectional study.

Streptococcus pneumoniae is an important cause of infection and commonly colonizes the nasopharynx of young children, along with other potentially pathogenic bacteria. The objectives of this study were to estimate the carriage prevalence of S. pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Staphylococcus aureus in young children in Indonesia, and to examine interactions between these bacterial species. 302 healthy children aged 12-24 months were enrolled in community health centers in the Bandung, Central Lombok, and Padang regions. Nasopharyngeal swabs were collected and stored according to World Health Organization recommendations, and bacterial species detected by qPCR. Pneumococcal serotyping was conducted by microarray and latex agglutination/Quellung. Overall carriage prevalence was 49.5% for S. pneumoniae, 27.5% for H. influenzae, 42.7% for M. catarrhalis, and 7.3% for S. aureus. Prevalence of M. catarrhalis and S. pneumoniae, as well as pneumococcal serotype distribution, varied by region. Positive associations were observed for S. pneumoniae and M. catarrhalis (OR 3.07 [95%CI 1.91-4.94]), and H. influenzae and M. catarrhalis (OR 2.34 [95%CI 1.40-3.91]), and a negative association was found between M. catarrhalis and S. aureus (OR 0.06 [95%CI 0.01-0.43]). Densities of S. pneumoniae, H. influenzae, and M. catarrhalis were positively correlated when two of these species were present. Prior to pneumococcal vaccine introduction, pneumococcal carriage prevalence and serotype distribution varies among children living in different regions of Indonesia. Positive associations in both carriage and density identified among S. pneumoniae, H. influenzae, and M. catarrhalis suggest a synergistic relationship among these species with potential clinical implications.

Risk factors associated with nasopharyngeal carriage and density of Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Staphylococcus aureus in young children living in Indonesia.

BACKGROUND: Potentially pathogenic bacteria Streptococcus pneumoniae, Haemophilus influenzae, Moraxella catarrhalis, and Staphylococcus aureus are commonly carried in the nasopharynx of young children. Host and environmental factors have been linked with pathogen carriage, and in many studies rural children have higher carriage rates than their urban counterparts. There are few published data on what factors contribute to increased pathogen density. The objectives of this study were to identify risk factors for nasopharyngeal carriage and density of S. pneumoniae, H. influenzae, M. catarrhalis, and S. aureus in young children in Indonesia. METHODS: Risk factor analysis was done using data on bacterial carriage and participant characteristics from a cross-sectional study that enrolled 302 children aged 12-24 months living in urban or semi-rural areas of Indonesia. Associations between host factors and odds of pathogen carriage were explored using logistic regression. Characteristics identified to be independent predictors of carriage by univariable analysis, as well as those that differed between urban and semi-rural participants, were included in multivariable models. Risk factors for increased pathogen density were identified using linear regression analysis. RESULTS: No differences in carriage prevalence between urban and semi-rural children were observed. Multiple children under the age of 5 years in the household (< 5y) and upper respiratory tract infection (URTI) symptoms were associated with S. pneumoniae carriage, with adjusted odds ratios (aOR) of 2.17 (95% CI 1.13, 4.12) and 2.28 (95% CI 1.15, 4.50), respectively. There was some evidence that URTI symptoms (aOR 1.94 [95% CI 1.00, 3.75]) were associated with carriage of M. catarrhalis. Children with URTI symptoms (p = 0.002), and low parental income (p = 0.011) had higher S. pneumoniae density, whereas older age was associated with lower S. pneumoniae density (p = 0.009). URTI symptoms were also associated with higher M. catarrahlis density (p = 0.035). Low maternal education (p = 0.039) and multiple children < 5y (p = 0.021) were positively associated with H. influenzae density, and semi-rural residence was associated with higher S. aureus density (p < 0.001). CONCLUSIONS: This study provides a detailed assessment of risk factors associated with carriage of clinically-relevant bacteria in Indonesian children, and new data on host factors associated with pathogen density.

The immunogenicity, safety, and consistency of an Indonesia combined DTP-HB-Hib vaccine in expanded program on immunization schedule.

BACKGROUND: WHO recommended incorporation of Haemophilus influenzae type b (Hib) vaccination into immunization program. Indonesia would adopt Hib as a National Immunization Program in 2013. We aimed at analyzing immunogenicity, safety, and consistency of a new combined DTP-HB-Hib (diphtheria-tetanus-pertussis-Hepatitis B-Haemophilus influenza B) vaccine. METHODS: A prospective, randomized, double blind, multicenter, phase III study of Bio Farma DTP-HB-Hib vaccine conducted in Jakarta and Bandung, August 2012 - January 2013. Subjects were divided into three groups with different batch number. Healthy infants 6-11 weeks of age at enrollment were immunized with 3 doses of DTP-HB-Hib vaccine with interval of 4 weeks, after birth dose of hepatitis B vaccine. Blood samples obtained prior to vaccination and 28 days after the third dose. Safety measures recorded until 28 days after each dose. RESULTS: Of 600 subjects, 575 (96 %) completed study protocol. After 3 doses, 100.0 and 96.0 % had anti-PRP concentration ≥0.15 and ≥1.0 µg/ml. Anti-diphtheria and anti-tetanus concentration ≥0.01 IU/ml detected in 99.7 and 100.0 %; while concentration ≥0.1 IU/ml achieved in 84.0 and 97.4 %. Protective anti-HBs found in 99.3 %. The pertussis vaccine response rate was 84.9 %. None Serious Adverse events (SAEs) considered related to study vaccine or procedure. CONCLUSIONS: The 3-dose of DTP-HB-Hib was immunogenic, well tolerated and suitable for replacement of licensed-equivalent vaccines based on immunologic and safety profiles. TRIAL REGISTRATION: NCT01986335 - October 30(th) 2013.