RESUMO
BACKGROUND: Hepatitis is a major cause of healthcare burden in India. Hepatitis A is the most common cause of acute viral hepatitis in the pediatric population whereas hepatitis E virus (HEV) is the most important cause of epidemic hepatitis. Various other causes of acute infective hepatitis in children are dengue, malaria, and enteric fever. The aim of the present study is to understand the clinico-serological profile in cases of acute infective hepatitis in children. Methodology: The present study is a cross-sectional study that was carried out from 1 September 2017 to 31 March 2019. A total of 89 children in the age group 1-18 years with clinically suspected acute infective hepatitis and subsequent confirmation on laboratory tests were included in the study. RESULTS: Hepatitis A (48.3%) was found to be the most common aetiology followed by dengue (22.5%) and hepatitis E (12.4%). No cases of hepatitis B or hepatitis C were found. The most common presenting complaint was fever (90%) and the most common clinical finding was icterus (69.7%). The sensitivity of icterus for the diagnosis of hepatitis was found to be 70%. Lab investigations showed a significant association between different etiologies of infective hepatitis with packed cell volume (PCV), white blood cell (WBC) count, and platelet count. Levels of aspartate aminotransferase (AST) and alanine transaminase (ALT) were raised in samples of patients with hepatitis A, hepatitis E, and combined hepatitis A and E infection as compared to other causes. All cases of hepatitis A and E were diagnosed with positive IgM antibody tests to the respective viral antigens. The most common complication was hepatic encephalopathy which was seen in patients with hepatitis A, dengue, and septicemia. Around 99% of patients recovered well and were discharged. One death occurred in a case of septicemia with septic shock with multiple organ dysfunction syndrome (MODS). CONCLUSION: The most common cause of infective hepatitis in children is hepatitis A. Other causes like dengue, malaria, and typhoid should also be kept in mind. The absence of icterus does not rule out hepatitis. Lab investigations including serology are important to confirm the diagnosis of various causes of hepatitis. Timely immunization against hepatitis is strongly recommended.
RESUMO
Efficacy and safety data on quadrivalent influenza vaccines (QIVs) for immunization of Indian children are scarce. This phase 3, registration study evaluated the immunogenicity, safety, and tolerability of a QIV in Indian children aged 6-35 months (Group 1) and 3-17 y (Group 2). Subjects received one or two doses (0.5 mL each) of the study vaccine based on their priming status. Immunogenicity (post-vaccination geometric mean fold increase in hemagglutination inhibition [HI] titers and proportion of patients with seroprotection and seroconversion against the four influenza strains), unsolicited adverse events (AEs), and tolerability were analyzed. Among 118 subjects enrolled in each group, the geometric mean(standard deviation) fold increase in HI titers against A(H3N2), A(H1N1), B(Victoria), and B(Yamagata) strains were 31.7(5.33), 10.5(6.06), 4.1(5.70), and 8.6(5.34) in Group 1 and 14.0(4.37), 9.2(4.26), 14.3(6.73), and 14.4(5.41) in Group 2, respectively. Seroprotection was achieved by 91.2%, 83.3%, 41.2%, and 68.4% subjects in Group 1 and 100%, 95.8%, 73.7%, and 89.8% subjects in Group 2, respectively. Seroconversion was achieved by 87.7%, 66.7%, 41.2%, and 64.9% subjects in Group 1 and 89.0%, 78.8%, 69.5%, and 75.4% subjects in Group 2, respectively. Vaccination site pain and fever were the most common local and systemic reactions, respectively. Systemic reactions were more frequent in Group 1 (16.9% vs 7.6%). Most subjects (>90%) did not experience inconvenience within 7 d of vaccination; <10% in both groups reported unsolicited AEs. Thus, the QIV had a positive benefit/risk profile in Indian children/adolescents aged 6 months to 17 y.CTRI Registry No: CTRI/2018/05/014191Registry Name: Clinical Trials Registry - IndiaDate of Trial Registration: May 29, 2018Study Dates: August 03, 2018 (first subject first visit) to January 31, 2019 (last subject last visit)Drugs Controller General of India [DCGI] permission letter number: CT-03/2018.
