Safety of Russian-Backbone Trivalent, Live Attenuated Seasonal Influenza Vaccine in Healthy Subjects: Open-Label, Non-randomized Phase 4 Study.

INTRODUCTION AND AIM: A trivalent live attenuated influenza vaccine (Nasovac-S®) was developed and licensed in India. A phase 4 study was conducted to assess safety. METHODOLOGY: This non-randomized, open-label, single-arm study among individuals ≥ 2 years of age involved administration of 0.5 mL of Nasovac-S intranasally, with a 1-month follow-up after vaccination. Adverse events (AEs) were collected via structured diaries. RESULTS: Among 500 vaccinated subjects, 160 were between 2 and 17 years of age, 240 were 18-49 years old and 100 were 50 years and older. A total of 533 solicited reactions were reported. The majority of these reactions were mild, and almost all of them resolved without any sequelae. A total of 20% of subjects reported at least one local solicited reaction, and 23% reported at least one systemic solicited reaction. None of the 45 unsolicited AEs reported by 37 subjects (7.4%) were causally related to the study vaccine. CONCLUSIONS: The data from the study adds to the existing safety database of Nasovac-S. REGISTRY: Clinical Trials Registry of India (CTRI/2015/08/006074).

Live attenuated tetravalent (G1-G4) bovine-human reassortant rotavirus vaccine (BRV-TV): Randomized, controlled phase III study in Indian infants.

BACKGROUND: Rotavirus remains the leading cause of diarrhoea among children <5years. 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 14-16weeks 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 7days and unsolicited & serious adverse events 28days 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 50.1U/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.

Tender skin nodules in a newborn.

Subcutaneous fat necrosis of infancy is a rare disorder of subcutaneous adipose tissue that is sometimes complicated by hypercalcemia. Complete resolution is common. From the pediatrician's point of view, the disease is a rare but important cause of inconsolable cry in a newborn.

RUASN: a robust user authentication framework for wireless sensor networks.

In recent years, wireless sensor networks (WSNs) have been considered as a potential solution for real-time monitoring applications and these WSNs have potential practical impact on next generation technology too. However, WSNs could become a threat if suitable security is not considered before the deployment and if there are any loopholes in their security, which might open the door for an attacker and hence, endanger the application. User authentication is one of the most important security services to protect WSN data access from unauthorized users; it should provide both mutual authentication and session key establishment services. This paper proposes a robust user authentication framework for wireless sensor networks, based on a two-factor (password and smart card) concept. This scheme facilitates many services to the users such as user anonymity, mutual authentication, secure session key establishment and it allows users to choose/update their password regularly, whenever needed. Furthermore, we have provided the formal verification using Rubin logic and compare RUASN with many existing schemes. As a result, we found that the proposed scheme possesses many advantages against popular attacks, and achieves better efficiency at low computation cost.