Differentiating Biliary Atresia From Idiopathic Neonatal Hepatitis: A Novel Keratin 7 Based Mathematical Approach on Liver Biopsies.

BACKGROUND AND AIMS: Differentiating biliary atresia (BA) from idiopathic neonatal hepatitis (INH) is vital in routine pediatric practice. However, on liver biopsy, few cases offer a diagnostic challenge to discriminate these entities with certainty. Bile ductular reaction (DR), intermediate hepatobiliary cells (IHBC) and extra-portal ductules (EPD) indicate progenitor cell activation, as a response to various hepatic insults. The present study aims to quantify DR, IHBC and EPD by Keratin 7 (CK7) immunohistochemistry (IHC) in BA and INH and to devise a mathematical approach to better differentiate the two, especially in histologically equivocal cases. METHODS: A total of 98 cases were categorized on biopsy as BA, INH or equivocal histology, favoring BA or INH. CK7 DR mean, IHBC mean and EPD mean values were compared between BA and INH. A formula was derived to help distinguish these two entities, the cut-off value, sensitivity and specificity of which were determined by receiver operating characteristic (ROC) curve. This formula was applied and validated on histologically equivocal cases. RESULTS: Univariate logistic regression revealed significant difference between BA and INH with respect to CK7 DR and CK7 EPD mean (p < 0.001 in both); however, CK7 IHBC mean was not significant (p = 0.08). On multivariate logistic regression, only CK7 DR had significant impact on diagnosis (p < 0.001). A formula: (CK7 DR)2 + (CK7 EPD)/(CK7 IHBC) was derived to help distinguish BA from INH. Cut off value of 10.5 and above, determined by ROC curve, favored a diagnosis of BA (sensitivity= 93.4%, specificity= 94.6%). Histologically equivocal and discrepant cases could be correctly categorized using this formula. CONCLUSIONS: Formula using CK7 IHC parameters may aid pathologists better distinguish BA from INH, especially in histologically equivocal cases.

Pediatric prescribing in tertiary care teaching hospital of Delhi (India): fragmenting medicines for use.

Lack of availability of age-appropriate dosage forms for children often results in use of adult dosage forms, which are administered to children after crushing or breaking. This can result in inappropriate doses being given to the children. This study was done to assess the prescribing pattern of use of medicines that had to be fragmented or crushed for use in relation to the age of the child. A prescription audit of 1200 outpatients and 400 inpatient records was done in the pediatric department of Lok Nayak tertiary care teaching hospital in the National Capital New Delhi, India. A structured pro forma was used for collecting the data. The total medicines prescribed, use of adult formulations, and number of adult medicines that had to be fragmented or broken for administration to pediatric patients were assessed. A total of 880 medicines were prescribed among inpatients and 2701 in outpatients. In inpatients, 230 (26.1%) medicines and in outpatients, 1013 (37.5%) medicines were fragmented before use. Some of these medicines were available in liquid oral dosage forms in Delhi Essential Medicine List (DEML) and should be available in the hospital. Medicines for use for common conditions were fragmented. Maximum use of fragmented medicines was in the age group of 6-9 years, both among inpatients and outpatients. Association of fragmentation with age was significant (p value < 0.05).Conclusion: Children are being prescribed dosage forms, requiring manual fragmentation or crushing. Policy changes and measures to make available age-appropriate pediatric dosage formulations need to be taken to improve pediatric pharmacotherapy in the hospital and health system. What is Known: • The dosage formulation prescribed to a patient can impact the patient's compliance with the therapy, accuracy of dosing, and patient and care providers' safety. • Lack of availability of age-appropriate dosage forms is common for children and often results in administration of adult dosage forms after crushing or breaking. What is New: • Some regularly prescribed medicines (14) including amoxicillin, albendazole, chloroquine, carbamazepine, valproate, and phenytoin that had to be fragmented were available in liquid oral dosage forms in the Delhi Essential Medicine List (DEML). • Despite being included in the EML, the patient has been denied access to appropriate medicines. It indicates a lack of concern and sensitivity about what is required for rational prescribing to children.

Thrombophilia Profile of Portal Vein Thrombosis in Young.

The abdominal vein thrombosis is an unusual and rare, but potentially a life threatening form of thrombosis. Much is known, studied and published about the venous thrombosis in the lower limbs and to some extent in upper limbs, where as the abdominal vein thrombosis still remains an unexplored area. The diagnosis of abdominal venous thrombosis has increased with awareness of the entity and the availability of better imaging modalities. Despite advances made in the management of venous thrombosis, the knowledge of events predisposing to abdominal thrombosis is largely unknown. This gap in knowledge needs to be studied and analyzed for better patient management. The study aims at analysing various risk factors in patients of abdominal venous thrombosis.

Side scatter versus CD45 flow cytometric plot can distinguish acute leukaemia subtypes.

BACKGROUND & OBJECTIVES: Flow cytometry is an important tool to diagnose acute leukaemia. Attempts are being made to find the minimal number of antibodies for correctly diagnosing acute leukaemia subtypes. The present study was designed to evaluate the analysis of side scatter (SSC) versus CD45 flow dot plot to distinguish acute myeloid leukaemia (AML) from acute lymphoblastic leukaemia (ALL), with minimal immunological markers. METHODS: One hundred consecutive cases of acute leukaemia were evaluated for blast cluster on SSC versus CD45 plots. The parameters studied included visual shape, CD45 and side scatter expression, continuity with residual granulocytes/lymphocytes/monocytes and ratio of maximum width to maximum height (w/h). The final diagnosis of ALL and AML and their subtypes was made by morphology, cytochemistry and immunophenotyping. Two sample Wilcoxon rank-sum (Mann Whitney) test and Kruskal-Wallis equality-of-populations rank tests were applied to elucidate the significance of the above ratios of blast cluster for diagnosis of ALL, AML and their subtypes. Receiver operating characteristic (ROC) curves were generated and the optimal cut-offs of the w/h ratio to distinguish between ALL and AML determined. RESULTS: Of the 100 cases, 57 of ALL and 43 cases of AML were diagnosed. The median w/h ratio of blast population was 3.8 for ALL and 1 for AML (P<0.001). ROC had area under curve of 0.9772.The optimal cut-off of the w/h ratio for distinction of ALL from AML was found to be 1.6. INTERPRETATION & CONCLUSIONS: Our findings suggest that if w/h ratio on SSC versus CD45 plot is less than 1.6, AML may be considered, and if it is more than 1.6, ALL may be diagnosed. Using morphometric analysis of the blast cluster on SSC versus CD45, it was possible to distinguish between ALL and AML, and their subtypes.

An Unsuspected Pharmacological Vitamin D Toxicity in a Child and its Brief Review of Literature.

Inordinate administration of Vitamin D beyond required doses and duration occurs as a sporadic event among frequent empirical therapies of pharmacological Vitamin D. Such instances lead to Vitamin D intoxication. Systemic hypertension is an unsuspected after-effect of Vitamin D toxicity in a child unlike other toxicity effects such as hypercalcemia, neurological deterioration, etc., Here, we report a case of a 1-year-old child who developed acute hypertension and severe hypercalcemia due to Vitamin D toxicity which was masked by initial dehydration such as illness and brief review of literature about clinical entity.

Safety and immunogenicity of a hexavalent DTwP-IPV-HB-PRP∼T vaccine versus separate DTwP-HB-PRP∼T and IPV vaccines in healthy infants in India.

Background: Multivalent vaccines containing whole-cell pertussis (wP) antigens combined with established diphtheria (D), tetanus (T), hepatitis B (HB), Haemophilus influenzae type b (Hib), and inactivated poliomyelitis (IPV) antigens allow the provision of a high-quality, affordable DTwP-IPV-HB-PRP∼T vaccine. Methods: Phase I/II, randomized, active-controlled, open-label study in healthy toddlers (Cohort I) and infants (Cohort II). Toddlers in Cohort I who had completed primary series D, T, P, HB, Hib, and polio vaccination received a booster dose of DTwP-IPV-HB-PRP∼T (N = 30) or DTwP-HB-PRP∼T + IPV (N = 15) vaccines at 15-18 months of age. After satisfactory review of safety data in Cohort I, infants in Cohort II received DTwP-IPV-HB-PRP∼T (N = 100) or DTwP-HB-PRP∼T + IPV (N = 50) at 6-8, 10-12, and 14-16 weeks of age. All infants in Cohort II had received previous oral polio and HB vaccines per country recommendations. Results: Booster and primary series vaccinations were well tolerated with no clinically significant differences between vaccine groups. Most adverse events were mild and resolved spontaneously; there were no vaccine-related serious adverse events and no deaths. In both vaccine groups, anti-D, anti-T, anti-HB, anti-Hib, and anti-polio 1, 2, and 3 seroprotection was 100% post-booster and post-primary series. For the pertussis antigens, booster response rate was > 86% in both groups. For the primary series, vaccine response rate was slightly higher for DTwP-IPV-HB-PRP∼T than DTwP-HB-PRP∼T + IPV for anti-PT (80.2% and 70.8%) and anti-FHA (81.3% and 68.8%), slightly lower for anti-PRN (72.5% and 81.3%), and similar in each group for anti-FIM (95.6% and 97.9%). Conclusions: This study demonstrated a good safety and immunogenicity profile of the hexavalent DTwP-IPV-HB-PRP∼T vaccine for infant primary series vaccination at 6-8, 10-12, and 14-16 weeks of age and booster vaccination at 15-18 months of age and supported progression to the next development phase.

Safety and immunogenicity of a tetravalent meningococcal serogroups A, C, W-135 and Y conjugate vaccine in adolescents and adults.

The highest incidence of invasive meningococcal disease is in young children, with a second peak in adolescents/young adults. All five major disease-causing serogroups (A, B, C, W-135 and Y) have been described in Asia. Immunogenicity and safety of the investigational meningococcal ACWY-tetanus toxoid conjugate vaccine (ACWY-TT, GlaxoSmithKline Biologicals) was evaluated in healthy, meningococcal conjugate vaccine-naïve adolescents in the Philippines, India and Taiwan. 1025 adolescents were randomized (3:1) to receive one dose of ACWY-TT or tetravalent ACWY polysaccharide vaccine (Mencevax™, Men-PS). Serum bactericidal activity using rabbit complement (rSBA) was measured. Local and systemic adverse reactions were recorded for 4 days. Safety data were pooled with results from a second, similarly designed study in adults for evaluation of grade 3 systemic events. The pre-specified immunogenicity criterion for non-inferiority to Men-PS was met. One month post-vaccination, ≥85.4%-97.1% had a vaccine response (post-titre ≥1:8 in initially seronegative and ≥4-fold increase in seropositive), versus 78.0%-96.6% after Men-PS, against each vaccine serogroup. Exploratory comparisons showed statistically significantly higher post-vaccination rSBA geometric mean titres against all serogroups following ACWY-TT versus Men-PS. Exploratory analysis showed no statistically significant differences between groups in grade 3 general symptoms; however, the statistical criterion for non-inferiority between pooled treatment groups in terms of the ratio of incidences of grade 3 general symptoms was not demonstrated. No SAEs were related to vaccination. ACWY-TT was immunogenic in Asian adolescents with a reactogenicity profile that was clinically acceptable and similar to that of licensed Men-PS. The results of this study indicate that ACWY-TT could be used as a third conjugate vaccine in the protection of adolescents against meningococcal disease.

Adherence to antiretroviral therapy and its correlates among HIV-infected children at an HIV clinic in New Delhi.

BACKGROUND: With the introduction of antiretroviral therapy (ART), the mortality and morbidity of HIV/AIDS have decreased markedly. However, high adherence to ART (>95%) is necessary for a good therapeutic outcome. There is a paucity of data on paediatric adherence to ART and its correlates from developing countries, particularly India. AIM: To determine the rate of adherence to ART in HIV-infected Indian children and the factors associated with adherence. METHODS: A cross-sectional study was conducted at an ART clinic in New Delhi, north India. Caregivers of 90 children were interviewed using a pre-designed, structured questionnaire and checklist. The primary measure of adherence was 4-day caregiver's recall. Adherence rates were correlated with 3-monthly CD4 counts. RESULTS: Mean (SD, range) adherence was 91·4% (12·3, 75-100%). Adherence was low (<95%) in 31 (34·4%) patients. On multivariate logistic regression analysis, increasing time since ART initiation (OR 1·08, 95% CI 1·02-1·13), low caregiver educational status (OR 4·19, 95% CI 1·37-10·88), orphanhood (OR 3·57, 95% CI 1·13-9·25), efavirenz-based ART regimens (OR 3·65, 95% CI 1·05-10·69) and female gender (OR 3·15, 95% CI 1·03-7·68) were associated with lower adherence. The rise in CD4 count after ART initiation was more marked in the high adherence group, with the difference in the two groups becoming statistically significant after 6 months of ART (median CD4 count 698 vs 355, p=0·016). CONCLUSIONS: It is possible to achieve high adherence to ART in a resource-limited setting. Caregiver recall is a reliable and inexpensive tool for measuring adherence. Paediatric adherence to ART is influenced by numerous factors and larger studies are needed to address the issue in India.

Availability of Pediatric Formulations in Public Health Care System in India: A Case Study.

OBJECTIVES: To assess the availability of pediatric formulations in Essential Medicines Lists and public health care facility in India. METHODS: Availability of pediatric formulations in the public health sector was evaluated by assessing inclusion of pediatric formulations in the National List of Essential Medicines (NLEM), Delhi Essential Medicine List (DEML), Indian Academy of Pediatrics (IAP) Essential Medicines Lists (EML) and comparing it with the World Health Organization's list of essential medicines for children (WHO, EMLc). In addition, availability of 30 essential medicines in a public, tertiary care hospital was assessed over a period of 1 y. RESULTS: Many medicines present in WHO EMLc were not there in NLEM and DEML. The number of pediatric medicines formulations not available in pediatric doses as compared to WHO EMLc was 98,97 and 97 in NLEM, DEML and IAP respectively. Palliative care was the most neglected area in all the lists. In the public health care facility, only 53% of the tracer pediatric medicines were available. CONCLUSIONS: There is less availability of pediatric formulations in the Indian NEML and state DEML. Availability of key tracer pediatric medicine formulations in public health facility is poor. A separate pediatric EML is required in the country to improve focus on availability of child-specific formulations.

Risk Stratification in Multiple Myeloma in Indian Settings.

Multiple myeloma (MM) constitutes 10% of all hematological malignancies. The last one decade has seen a phenomenal progress in the therapeutic options available for the management. Although it still remains incurable, with the advent of newer therapies, the median survival in many risk groups is now around 10 years. Conventional karyotyping of bone marrow samples has a positivity rate of 20-30% at diagnosis in patients of Multiple Myeloma. However, array Comparative Genomic Hybridisation (aCGH) has revealed that almost all MM patients have cytogenetic abnormalities which may affect the pathophysiology, selection of therapy and outcomes of the disease. The progress in the field of exploring the genetic landscape of multiple myeloma with multiple tools like Fluorescent in-situ hybridization, aCGH, Next Generation Sequencing, Flow cytometry, etc., combined with the traditional risk stratification markers like albumin, ß2 microglobulin and LDH, is gradually leading towards a risk-adapted therapy. The recent R-ISS risk stratification has combined these two group of information to validate a prognostic score which is an improvement over the past tools like DSS and ISS. In view of the plethora of information available on the multitude of cytogenetic markers there is a tendency to evaluate for all of them at diagnosis, especially in research centers. This leads to a significant increase in the cost of therapy of Multiple Myeloma in day-to-day clinical practice and an increased out-of-pocket spending to the patient, especially in resource-limited settings like India. Also, there is a variable approach to pre-therapy cytogenetic evaluation and risk stratification at different Hematology centres in the country, often dictated by financial constraints and availability of specialized tests. This review discusses the risk stratification markers and tools available in MM in 2019 and how it can be adapted in the resource constraint settings so as to derive the maximum prognostic information from a minimal prognostic panel, as well as lead to standardization of the prognostic protocols in resource limited settings across various Hematology centres in India.

Effect of Rehydration With Normal Saline Versus Ringer Lactate on Serum Sodium Level of Children With Acute Diarrhea and Severe Dehydration: A Randomized Controlled Trial.

OBJECTIVE: To demonstrate the equivalence of Normal Saline (NS) and Ringer Lactate (RL) for change in serum sodium levels during correction of severe dehydration in children with acute diarrhea based on World Health Organization (WHO) plan C. DESIGN: Equivalence randomized control trial. SETTING: Pediatric diarrhea unit of a tertiary care hospital from May, 2016 to April, 2017. PARTICIPANTS: 72 children of 1-12 years with acute diarrhea and severe dehydration were enrolled. Children with dysentery, severe acute malnutrition, severe anemia, meningitis, and known surgical and systemic diseases were excluded. INTERVENTION: RL (n=36) or NS (n=36) were used as per WHO plan C. Blood samples were drawn before intravenous fluid correction and 3 h post-intervention. OUTCOME MEASURES: Mean change in serum sodium level from the baseline between the RL and NS groups. RESULTS: 70 children (35 in each group) completed the study. The difference in mean serum sodium levels from baseline in RL and NS groups were 1.4 (4.5) mEq/L and 2.1(4.9) mEq/L, respectively (P=0.58). CONCLUSION: Both RL and NS are equivalent in terms of change in serum sodium from baseline for intravenous rehydration in children with acute diarrhea and severe dehydration.

Prevalence of celiac disease in north Indian children.

Celiac disease (CD) is being increasingly reported from the wheat-eating population of north India. However, the exact prevalence of CD in children is not known as population screening studies are scarce. Our study aimed to determine the prevalence of CD in 400 children, 6 months to 12 years of age attending pediatrics department of a tertiary care hospital in north India. The study population was screened for antitissue transglutaminase (tTG) antibodies. Endoscopic duodenal biopsy was done in the anti--tTG positive subjects. Four patients were diagnosed with CD as per the modified ESPGHAN criteria. The prevalence of CD thus was 1 %, which was in concordance with screening studies using serological markers conducted in the West.

Efficacy of first-line, WHO recommended generic HAART regimens in Indian children.

BACKGROUND: The clinical efficacy of highly active antiretroviral therapy (HAART) in children has been well documented in the developed countries, although most of the regimens are Protease Inhibitor (PI) based which are too expensive. To circumvent this problem World Health Organization (WHO) has recommended Non- Nucleotide Reverse Transcriptase Inhibitor (NNRTI) based regimen for resource-limited countries. AIM: To assess the long-term efficacy of first line World Health Organization (WHO)-recommended generic highly active antiretroviral therapy (HAART) regimens in treatment -naïve children. MATERIALS AND METHODS: Observational retrospective analysis was done. Thirty patients on HAART for >or= 6 months were included (27 on Stavudine; three on Zidovudine with Lamivudine/ Nevirapine). No protease inhibitors were used. RESULTS: Median age was seven years (Interquartile [IQR]: 5.62-8.50) and median duration on HAART was 18 months (IQR: 6-24). No new staging events were observed after six months of initiation of HAART. The median CD4% increased from 6.0 % at baseline to 15.5% at six months, 21.7% at 12 months, 25.4% at 18 months, 24.6 % at 24 months 25.3% at 30 months and 23.7% at 36 months. There was only one case of immunological failure. Stratifi ed analysis based on baseline CD4% show that even patients with a baseline CD4 % of <5% achieved percentage of >25% at 18-24 months and maintained it subsequently. Significant increase in the weight and body mass index Z scores was observed but significant fall in the height Z scores were observed. This sub group of patients with poor linear height velocity would require detailed endocrine evaluation after testing for viral loads. CONCLUSIONS: Non- Nucleotide Reverse Transcriptase Inhibitor based HAART regimens are feasible and effective in long term in resource-limited setting despite initiation of treatment in advanced stages. These can be continued in NACO/WHO scale up programmes at present for children.

Clinical spectrum of fever of unknown origin among Indian children.

BACKGROUND: Fever of unknown origin (FUO) is an important cause of morbidity and mortality in children, especially in tropical and developing countries. AIM: To determine the aetiology and outcome of FUO in Indian children. METHODS: A hospital-based, prospective, observational study was conducted over a 1-year period (2006-2007). Children aged > or =3 months to 12 years who qualified for the definition of FUO were recruited. Initial evaluation included complete blood count, peripheral smear for malarial parasites, erythrocyte sedimentation rate (ESR), urine analysis and culture, blood culture, tuberculin test and chest X-ray. RESULTS: Of 49 patients evaluated, a diagnosis was reached in 43 (88%). Infections were the predominant cause of FUO in 34 patients (69%). Enteric fever was the most common infection (14), followed by visceral leishmaniasis (10) and tuberculosis (5). The next most common cause was malignancy (6, 12%). Among the six undiagnosed patients, spontaneous resolution occurred in five whereas one child continued to be febrile without an established cause at the end of the study. CONCLUSION: Repeated, thorough clinical examination and carefully selected laboratory examinations proved useful in the diagnosis of FUO. Serology (e.g. enteric fever) and bone marrow examination (e.g. leishmaniasis, malignancy) were the most useful diagnostic tests.

Diarrhoeal outbreak of Vibrio cholerae 01 Inaba in Delhi.

V. cholerae O1 Eltor serotype Ogawa has been causing most of the cholera outbreaks in India till recently. However this communication reports the occurrence of Vibrio Cholerae O1 Inaba in Delhi in 2005, as a predominant causative organism of cholera in children. All strains isolated were sensitive to gentamicin and a high level of resistance towards nalidixic acid and amoxicillin was seen. There was no case fatality.

A Phase III open-label, randomized, active controlled clinical study to assess safety, immunogenicity and lot-to-lot consistency of a bovine-human reassortant pentavalent rotavirus vaccine in Indian infants.

BACKGROUND: A heat-stable bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, ROTASIIL®) was developed in India. In this study, the vaccine was tested for safety, immunogenicity and clinical lot-to-lot consistency. METHODS: This was a Phase III, open label, randomized, equivalence design study. The primary objective was to demonstrate lot-to-lot consistency of BRV-PV. Subjects were randomized into four arms, three arms received Lots A, B, and C of BRV-PV and the control arm, received Rotarix®. Three doses of BRV-PV or two doses of Rotarix® and one dose of placebo were given at 6, 10, and 14 weeks of age. Blood samples were collected four weeks after the third dose to assess rotavirus IgA antibody levels. The three lots of BRV-PV were equivalent if the 95% Confidence Intervals (CIs) of the geometric mean concentration (GMC) ratios were between 0.5 and 2. Solicited reactions were collected by using diary cards. RESULTS: The study was conducted in 1500 randomized infants, of which 1341 infants completed the study. The IgA GMC ratios among the three lots were around 1 (Lot A versus Lot B: 1.07; Lot A versus Lot C: 1.06; and Lot B versus Lot C: 0.99). The 95% CIs for the GMC ratios were between 0.78 and 1.36. The IgA GMCs were: BRV-PV group 19.16 (95% CI 17.37-21.14) and Rotarix® group 10.92 (95% CI 9.36-12.74) (GMC ratio 1.75; 90% CI 1.51-2.04). Seropositivity rates were 46.98% (95% CI 43.86-50.11) and 31.12% (95% CI 26.17-36.41). The incidence of solicited reactions was comparable across the four arms. No serious adverse events were associated with the study vaccines, except two gastroenteritis events in the BRV-PV groups. CONCLUSION: Lot-to-lot consistency of BRV-PV was demonstrated in terms of GMC ratios of IgA antibodies. The vaccine safety and immunogenicity profiles were similar to those of Rotarix®. Clinical Trials.Gov [NCT02584816] and Clinical Trial Registry of India [CTRI/2015/07/006034].

Non-interference of Bovine-Human reassortant pentavalent rotavirus vaccine ROTASIIL® with the immunogenicity of infant vaccines in comparison with a licensed rotavirus vaccine.

BACKGROUND: A newly developed bovine-human reassortant pentavalent vaccine (BRV-PV, ROTASIIL®) was tested for its potential effect on the immunogenicity of concomitantly administered EPI vaccines in infants in a randomized controlled study in India. METHODS: In this Phase III, multicenter, open label, randomized, controlled study, three doses of BRV-PV or two doses of Rotarix® and one dose of placebo were given to healthy infants at 6, 10, and 14 weeks of age. Subjects also received three doses of DTwP-HepB-Hib (diphtheria, tetanus, whole-cell pertussis, hepatitis B, and haemophilus influenzae type b conjugate - pentavalent vaccine) and oral polio vaccine concomitantly at 6, 10, and 14 weeks of age and a single dose of inactivated polio vaccine at 14 weeks of age. Blood samples were collected four weeks after the final vaccination to assess immune responses to all the vaccines administered. For diphtheria, tetanus, hepatitis B, Hib, polio type 1, and polio type 3 antibodies, non-interference was to be supported if the lower limit of the two-sided 90% confidence interval (CI) for the seroprotection rate difference for the BRV-PV group minus the Rotarix® group was >10.0%. For pertussis antibodies, non-interference was to be supported if the lower limit of the two-sided 90% CI for the ratio of geometric mean concentrations (GMCs) was >0.5. RESULTS: A total of 1500 infants were randomized to either BRV-PV (1125 infants) or Rotarix® (375 infants), of which 1341 completed the study as per the protocol. More than 97% of subjects achieved seroprotective antibody titres against diphtheria, tetanus, hepatitis B, Hib, polio type 1, and polio type 3 in both groups. The difference in seroprotection rates between the BRV-PV group and the Rotarix® group for all these antibodies was less than 1%. The ratio of GMCs of anti-pertussis IgG concentrations for the BRV-PV group versus Rotarix® was 1.04 [90% CI: 0.90; 1.19]. CONCLUSION: BRV-PV does not interfere with the immunogenicity of concomitantly administered routine infants vaccines.

Safety and reactogenicity of a low dose diphtheria tetanus acellular pertussis vaccine (Boostrix) in pre-school Indian children.

OBJECTIVE: To evaluate the safety and reactogenicity of a reduced-antigen-content combined Diphtheria Tetanus Acellular Pertussis (dTpa) vaccine in Indian preschool children. METHODS: GlaxoSmithKline Biologicals combination dTpa vaccine was administered as a single booster dose to 347 children aged 46 years in seven centers across India. All children were subsequently followed up for two weeks for safety and reactogenicity assessment. RESULTS: A total of 345 subjects completed the study and two subjects were lost to follow-up. One serious adverse event (head injury) unrelated to vaccination was reported. Otherwise, all subjects were in good health throughout the study period. Three subjects (0.9%) reported transient general symptoms (such as irritability and drowsiness), which prevented normal activity. Pain at injection site, swelling and redness was reported in 31.1%, 18.2% and 8.9% subjects respectively. Five subjects (1.4%) reported severe pain preventing normal movement. This resolved within 48 hours in all cases. There were no other severe local reactions including large injection site reactions. CONCLUSION: The reduced antigen content combined dTpa vaccine is safe and well tolerated in Indian pre-school children.

Introduction of New Vaccines in State Immunization Schedule - Delhi's Experience.

Immunization is an established, cost-effective, preventive intervention to improve child survival. To provide protection against vaccine preventable diseases, all countries in the world have an immunization program that offers selected vaccines to the eligible beneficiaries. In India, Expanded Program of Immunization was started in 1978, and then Universal Immunization Program was launched in 1985 with six antigens. This article describes the experience with institutionalization of four state-specific vaccines by Delhi in its immunization schedule to enlarge the ambit of immunization services. It attempts to highlight the state's perspective in terms of the implementation policy, operational strategy adopted and evolution of immunization program in the state over 16 years.