KPC Medical College & Hospital
KPC Medical College & Hospital
Saluja T.,Shantha Biotechnics |
Palkar S.,Bharati Vidyapeeth Deemed University |
Misra P.,All India Institute of Medical Sciences |
Gupta M.,Post Graduate Institute of Medical Education and Research |
And 17 more authors.
Vaccine | Year: 2017
Background Rotavirus remains the leading cause of diarrhoea among children <5 years. We assessed immunogenic non-inferiority of a tetravalent bovine-human reassortant rotavirus vaccine (BRV-TV) over the licensed human-bovine pentavalent rotavirus vaccine RV5. Methods Phase III single-blind study (parents blinded) in healthy infants randomized (1:1) to receive three doses of BRV-TV or RV5 at 6–8, 10–12, and 14–16 weeks of age. All concomitantly received a licensed diphtheria, tetanus, pertussis, hepatitis B, Haemophilus influenzae type b conjugate vaccine (DTwP-HepB-Hib) and oral polio vaccine (OPV). Immunogenic non-inferiority was evaluated in terms of the inter-group difference in anti-rotavirus serum IgA seroresponse (primary endpoint), and seroprotection/seroresponse rates to DTwP-HepB-Hib and OPV vaccines. Seroresponse was defined as a ≥4-fold increase in titers from baseline to D28 post-dose 3. Non-inferiority was declared if the difference between groups (based on the lower limit of the 95% confidence interval [CI]) was above −10%. Each subject was evaluated for solicited adverse events 7 days and unsolicited & serious adverse events 28 days following each dose of vaccination. Results Of 1195 infants screened, 1182 were randomized (590 to BRV-TV; 592 to RV5). Non-inferiority for rotavirus serum IgA seroresponse was not established: BRV-TV, 47.1% (95%CI: 42.8; 51.5) versus RV5, 61.2% (95%CI: 56.8; 65.5); difference between groups, −14.08% (95%CI: −20.4; −7.98). Serum IgA geometric mean concentrations at D28 post-dose 3 were 28.4 and 50.1 U/ml in BRV-TV and RV5 groups, respectively. For all DTwP-HepB-Hib and OPV antigens, seroprotection/seroresponse was elicited in both groups and the −10% non-inferiority criterion between groups was met. There were 16 serious adverse events, 10 in BRV-TV group and 6 in RV5 group; none were classified as vaccine related. Both groups had similar vaccine safety profiles. Conclusion BRV-TV was immunogenic but did not meet immunogenic non-inferiority criteria to RV5 when administered concomitantly with routine pediatric antigens in infants. © 2017 Elsevier Ltd
Mukherjee D.,KPC Medical College & Hospital |
Das C.,BS Medical College & Hospital |
Paul D.,BS Medical College & Hospital
Indian Journal of Otolaryngology and Head and Neck Surgery | Year: 2016
Brain abscess is the ultimate otogenic complication, both in severity and difficulty of management. In developing countries with high incidence of cholesteatoma, brain abscess is not a rare complication. In India, brain abscesses constitute about 8 % of all intracranial lesions. The surgical treatment of brain abscess is very controversial. This prospective study was done in ENT department of a tertiary care hospital in Kolkata, during the period from May 2009 to April 2014. 22 such cases of otogenic brain abscess managed by single-stage trans-mastoid drainage along with meticulous mastoid clearance. On the basis of clinical, radiological and operative findings, data of all patients with otogenic brain abscess were analyzed. There was male predominance and 9 (40.91 %) of them were younger than 20 years. 15 (68.18 %) cases were of cerebellar abscess and in 7 (31.82 %) cases were of the temporal abscess. Lateral sinus thrombosis was the most common associated complication found (22.73 %) in our study. All the patients peri-operatively revealed cholesteatoma. All the patients recovered well and there was no recurrence of symptoms on a minimum 15 months follow-up. This approach suits the otologists in clearing the cause and effect of pathology, at the same sitting. This single-stage approach decreases the peri-operative morbidity and mortality of the two-stage procedure. It also decreases the hospital stay and financial burden. © 2016, Association of Otolaryngologists of India.
PubMed | ESIC Hospital & ODC EZ and KPC Medical College & Hospital
Type: Journal Article | Journal: Indian journal of clinical biochemistry : IJCB | Year: 2014
Lead poisoning presents a common acquired as well as congenital environmental threat to childrens health today. An unusual case of severe lead poisoning in breast fed male infant is presented here. The objective of the study is to describe a patient who developed clinical lead intoxication with an uncommon source of poisoning. A 6months old male baby presented with gradual loss of weight, not feeding well and persistent vomiting. Laboratory investigation revealed that he was having anemia (Hb level 5.4gm/dl), abnormal liver enzymes (including elevated transaminase activity) and high blood lead value (83g/dl). RBC morphology showed basophilic stippling with cabot ring, suggestive of a case of lead poisoning. A course of chelation treatment using calcium versenate (EDTACaNa2) was prescribed following which a radical solution for mobilization of lead from his systems was observed.