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Objective: To evaluate the safety and immunogenicity of an indigenous hepatitis B, diphtheria, tetanus and B. pertussis tetravalent vaccine (Shantetra) in comparison with Tritanrix HBTM in healthy Indian infants., Design: Multicentric, randomized, single blind intention-to-treat study with 12-18 weeks of follow up period., Setting: 5 out patient departments at tertiary care referral centers across India., Participants: 151 infants were randomized in a 2:1 ratio to recruit 101 in the Shantetra and 50 in the Tritanrix HBTM groups respectively. A total of 136 subjects completed the study. No patients were withdrawn from the study due to any adverse effects., Interventions: Recruited subjects were randomized to receive three doses of either of the two DTPw-Hepatitis B combination vaccines as per the EPI schedule., Main Outcome Measures: Monitoring the humoral immune response (seroconversion rates) induced by each antigenic component three to six weeks after the last dose of vaccine in both the groups., Results: Seroprotective immune response was observed in 98.9% subjects for diphtheria, tetanus and hepatitis B components in the Shantetra group as compared to 95.5% subjects in the Tritanrix HB group. Anti pertussis antibody response was seen in 89% and 91.1% in the Shantetra and Tritanrix HB groups, respectively. The commonly observed adverse events in both the groups were, pain at injection site, mild fever and transient crying., Conclusion: The safety and immunogenicity of indigenously developed DTPwHepatitis B combination vaccine was demonstrated in the present study.

Necrotizing enterocolitis was found in 77 infants over a 5 year period. Diagnosis of NEC was established on 4.9 + 4.8 days in babies with birth weight of 1667 + 577 grams and the gestational age of 33.3 + 2.6 weeks. Definite disease occurred in 33 (42.9%) babies while there was strong suspicion in another 44 (57.1%) babies. Prefeed gastric residue (98.7%), abdominal distension (97.3%), lethargy (78.7%), hypotonia (60%) and jaundice (48%) were the main presenting features. However, blood in stools and abdominal wall erythema were found in 38.7% babies. About one third of infants had a positive blood culture. Pneumatosis intestinalis was present in 83.9% of babies and pneumoperitoneum was seen in 35.5% of neonates with NEC. Ileo-ceco-colic region was the commonest site of involvement. Overall survival was 61% and survival with Stage III was only 13%. Birth weight less than 1500 g, gestational age less than 32 weeks, erythema of the abdominal wall, intra-abdominal mass, portal venous gas in abdominal X-ray and Gram negative septicemia were associated with higher mortality.

Necrotizing enterocolitis (NEC) was diagnosed in 77 infants among 2200 admissions to the NICU during the period January 1986 to September 1990. The incidence was 0.5% of all live births and 3.5% of NICU admissions. Majority (57.1%) had Stage I of the disease while 23.4% had Stage II and 19.5% had Stage III of the disease. The average birth weight of the babies was 1650 +/- 577 g and gestational age 33.3 +/- 2.6 weeks. Majority (53.2%) were very low birth weight (VLBW) babies. Incidence was significantly more (5.7% vs 0.25%, p < 0.001) in VLBW infants and in preterm infants of gestational age less than 32 weeks (5.2% vs 0.09%, p < 0.001). Multiple risk factors were present in these babies while 8 babies did not have any risk factor. Risk of developing NEC was significantly more if infants had any of these risk factor (p < 0.001). Incidence of severe birth asphyxia was more in Stage I cases (35.7% vs 10.3%, p < 0.05). The age at presentation was 4.9 +/- 4.8 days and majority (96%) presented during the first 14 days. The overall survival was 61% and was 70.5, 77.8 and 13.3% in Stages I, II and III, respectively. VLBW and preterm infants had a higher mortality.