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Introduction We conducted a randomized, observer-blind, non-inferiority, parallel-group clinical study of diphtheria, tetanus, pertussis, hepatitis B, and Haemophilus influenzae type b conjugate (pentavalent) vaccination of infants in India. Goals were to determine whether the seropositivity rate after vaccination via disposable-syringe jet injector (DSJI) was non-inferior to that via needle and syringe (N-S), and to compare the safety of vaccination by the two methods. Methods Healthy children received a three-dose series of vaccine intramuscularly by DSJI or N-S beginning at 6–8 weeks of age. Immunoglobulin G antibody levels were measured by ELISA at 4–6 weeks after the third dose. The main secondary endpoint was safety, measured as injection site and systemic reactions. Discussion The study was stopped early out of caution beyond that specified in the protocol stopping criteria, after the Data Safety Committee noted a higher frequency of injection site reactions, especially moderate and severe, in the DSJI group. As a result, 128 subjects—DSJI group 61; N-S group 67—completed the study, rather than the 340 planned, and the study was not sufficiently powered to compare immunogenicity endpoints for the groups. Descriptive statistics indicate that seropositivity induced by vaccination with the DSJI was similar to that of N-S for all five antigens. Pentavalent vaccine includes whole-cell pertussis vaccine and an aluminum adjuvant, which may have contributed to the higher number of local reactions with the DSJI. The reactions caused no serious or long-term sequelae, and may be more acceptable in other populations or circumstances. US National Institutes of Health clinical trials identifier: NCT02409095.

Low adolescent peak bone mass is associated with bone problems in adulthood. Our aim was to assess underprivileged premenarchal Indian girls for low bone mineral content and to study the infl uence of anthropometric, lifestyle factors on bone health. Data on anthropometry, diet, lifestyle, total body bone mineral content (TBBMC), bone area, bone mineral density, and biochemical parameters [parathyroid hormone, vitamin D (25OH-D), calcium, and zinc] were assessed in 214 premenarchal girls (8 -12 years). Compared with the Indian reference database, 15.6 % girls had TBBMC for age Z-scores below -2 and 37.5 % had Z-scores between -2 and -1. The TBBMC for total body bone area Z-scores were below -2 for one fi fth of girls, indicating undermineralized bones. Mean rate of increase in TBBMC with age and Tanner stage was lower in our study population (11.6 % and 20.7 % , respectively) than reference database (14.2 % and 33.4 % , respectively). Low weight, 25OH-D, and intake of protein, calcium, and zinc adversely affected TBBMC (p < 0.05). Many underprivileged premenarchal Indian girls are at risk of achieving low bone mass. Steps to improve underweight, 25OH-D, intakes of protein, calcium, and zinc might improve bone health.

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