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Background Diphtheria cases continue to be reported in Indonesia, which has long been one of the countries with the highest number of diphtheria cases worldwide. One of Indonesia's province with the highest annual diphtheria cases is West Java. Dr. Hasan Sadikin General Hospital (RSHS) is one of the tertiary referral hospitals in Bandung, West Java, that treats several diphtheria cases annually. No study focused on the clinical characteristics of diphtheria cases in children admitted to RSHS between 2017 and 2021 yet. Therefore, this study sought to analyze that. Objective To find out the profiles of children =18-year-old with diphtheria admitted in RSHS between 2017-2021. Methods This descriptive, cross-sectional study reviewed the medical records of diphtheria patients 0 to 18-year-old who were admitted to RSHS between year 2017 and 2021. Results Out of 45 subjects, 76% were males. The median of age was eight years old, ranging from 2 to 17 years. Most patients lived in urban areas and had normal anthropometry status, although some showed abnormal findings. The data showed that 44% had more than 3 days of onset until admission to the hospital, and the median length of stay was 9 days. The clinical characteristics showed that 91% of patients had pseudomembrane, also present with cough, common cold, hoarseness, stridor, and bull's neck. As many as 44% of patients did not have complete basic immunization status. Complications found were airway obstructions, myocarditis, and sepsis, and 2 deaths were reported. Conclusion Pseudomembrane was found in the majority of patients. Most patients were over five years of age, and almost half number of the patients did not have complete basic immunization status, indicating the need for improved immunization and booster coverage. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]