Safety and immunogenicity of a multidose vial formulation of 13-valent pneumococcal conjugate vaccine administered with routine pediatric vaccines in healthy infants in India: A phase 4, randomized, open-label study.

PURPOSE: This phase 4, randomized, open-label, multicenter study in healthy Indian infants and toddlers evaluated the safety, tolerability, and immunogenicity of the 13-valent pneumococcal conjugate vaccine (PCV13) formulated in a multidose vial (MDV) or single prefilled syringe (PFS). METHODS: Healthy Indian infants (6 weeks of age) were randomized 1:1 to receive either PCV13-MDV or PCV13-PFS concomitant with routine pediatric vaccines. Subjects received a single dose of either PCV13-MDV or PCV13-PFS as a 4-dose schedule (infant series: 1 dose at 6, 10, and 14 weeks of age; toddler dose: 12 months of age). Safety was assessed, including local reactions, systemic events, and adverse events (AEs). Immunogenicity 1 month after both the infant series and toddler dose was measured by concentrations of serotype-specific immunoglobulin G (IgG) antibodies and opsonophagocytic activity titers. RESULTS: Rates and severities of local reactions and systemic events up to 7 days after each dose of either PCV13-MDV or PCV13-PFS were generally similar, with the majority being of mild or moderate severity. PCV13-MDV had a safety profile comparable with PCV13-PFS; both groups experienced a similar frequency of AEs. PCV13-MDV elicited immune responses comparable with those induced by PCV13-PFS. Clear boosting of immune responses after the PCV13-MDV toddler dose was observed; ≥96% of subjects showed serotype-specific IgG concentrations at or above the defined thresholds 1 month after the PCV13-MDV toddler dose. CONCLUSIONS: PCV13-MDV was safe, well tolerated, and immunogenic in healthy Indian infants and toddlers when coadministered with routine pediatric vaccinations. Safety and immunogenicity of PCV13-MDV was comparable with PCV13-PFS. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov: NCT03548337.

Current status of neonatal intensive care in India.

Globally, newborn health is now considered as high-level national priority. The current neonatal and infant mortality rate in India is 29 per 1000 live births and 42 per 1000 live births, respectively. The last decade has seen a tremendous growth of neonatal intensive care in India. The proliferation of neonatal intensive care units, as also the infusion of newer technologies with availability of well-trained medical and nursing manpower, has led to good survival and intact outcomes. There is good care available for neonates whose parents can afford the high-end healthcare, but unfortunately, there is a deep divide and the poor rural population is still underserved with lack of even basic newborn care in few areas! There is increasing disparity where the 'well to do' and the 'increasingly affordable middle class' is able to get the most advanced care for their sick neonates. The underserved urban poor and those in rural areas still contribute to the overall high neonatal morbidity and mortality in India. The recent government initiative, the India Newborn Action Plan, is the step in the right direction to bridge this gap. A strong public-private partnership and prioritisation is needed to achieve this goal. This review highlights the current situation of neonatal intensive care in India with a suggested plan for the way forward to achieve better neonatal care.