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This first in human study was designed as an open label clinical trial to assess the safety and immunogenicity of SIIPL DTwP-HepB-IPV-Hib (Hexavalent) combination vaccine in healthy toddlers, aged 16-24 months. A total of 24 healthy toddlers were administered a 0.5 ml single dose of SIIPL DTwP-HepB-IPV-Hib vaccine intramuscularly, and followed for 28 days for safety outcomes viz. immediate, solicited, unsolicited and serious adverse events. Blood samples were collected immediately prior to and 28 days after vaccination to assess the immunogenicity. Twenty four completed the study in compliance with the study protocol. None of the participants experienced any immediate or any serious adverse event. In terms of the frequency and intensity, the adverse events were comparable to DTwP-based combination vaccines. The vaccine elicited a strong booster response as demonstrated by a large increase in antibodies against all vaccine antigens. One month post booster vaccination seroprotection for diphtheria, tetanus, Hepatitis B

Introduction: The coronavirus disease (COVID)-19 pandemic has affected nearly every facet of life, including clinical research, and has had an adverse and extensive impact on clinical trials including pediatric vaccine trials. Across the globe, countries implemented a variety of restrictions to people’s everyday lives, which have substantially impacted the ability to conduct pediatric vaccine trials. Objectives: The objectives of the study were to assess the impact of the COVID-19 pandemic on enrollment and follow-up of clinical trial participants in pediatric vaccine clinical trials and simultaneously to explore various strategies used for overcoming these challenges during the COVID-19 pandemic period. Materials and Methods: Data of 10 pediatric vaccine clinical trials were obtained from the clinical trial records of the Clinical Research Unit. The number of subjects enrolled, number of study dropouts, protocol deviations, and reasons for participant dropout/deviations were recorded from these pediatric vaccine clinical trials carried out before and during the COVID-19 pandemic period from March to December 2020. These metrics were then compared with their counterparts recorded during our study to statistically assess the impact of the COVID-19 pandemic. Various factors which have affected the recruitment and follow-up in pediatric vaccine clinical trials and various strategies used to curtail subject dropout and protocol deviations during COVID-19 pandemic were studied in detail. Results: The primary and most visible impact of the COVID-19 pandemic was that protocol deviations and study dropouts were significantly higher for the trials conducted during COVID-19 pandemic period. The difference between proportion of protocol deviations and study dropouts in the pediatric vaccine clinical trials conducted during pandemic and trials conducted before pandemic was statistically significant (

Introduction: The enrollment of children into clinical trials is challenging. India is increasingly recognized as a site for clinical research due to its large population and growing research capabilities, though data regarding barriers for recruitment into pediatric vaccine clinical trials are scarce. Objective: The objective of this study was to assess the barriers in recruitment and to find out parental factors for non-participation of their babies in the vaccine clinical trial. Materials and Methods: This was a prospective cross-sectional non-interventional study which was carried out in the pediatric clinical research unit of a tertiary care multispecialty teaching hospital in Pune. The study social worker visited postnatal ward to prime mothers regarding the pneumococcal vaccine clinical trial. Parents of babies aged 6–8 weeks, who were eligible for participation in the ongoing pneumococcal vaccine trial were explained the informed consent form of this clinical trial and their willingness for participation was sought. The reason for refusal of the parents, who declined the study participation of their baby, was documented. Results: Even though eligible inborn baby pool was large (n=384), only 148 (38.54%) inborn babies were brought to our clinical research unit showing a major barrier in the recruitment. Of 204 babies who presented to clinical research unit, 94 babies (46.08%) were enrolled in the ongoing clinical trial and the majority of them were inborn (89.36%), whereas only 10 of 56 (17.86%) outborn babies were enrolled. There was no gender difference noted in enrolled versus non-enrolled babies. There was no significant association between baby’s gender and place of delivery. The major reasons for non-enrollment were “unwillingness” for participation in clinical trial (68.18%) followed by mothers going outstation, staying far away from our hospital, lack of time, and concerns due to research vaccine. Conclusion: Our study has shown that even though eligible inborn baby pool was large, only 38.54% of inborn babies were brought to our clinical research unit, thus a major barrier in recruitment. More effective counseling and recruitment strategies are needed to scale up the enrollment more so for the outborn babies.

A lyophilized bovine-human rotavirus reassortant pentavalent vaccine (BRV-PV, Rotasiil®) was licensed in 2016. A liquid formulation of this vaccine (LBRV-PV, Rotasiil - Liquid) was subsequently developed and was tested for non-inferiority to Rotasiil® and for lot-to-lot consistency.This Phase II/III, open label, randomized study was conducted at seven sites across India from November 2017 to June 2018. Participants were randomized into four arms; Lots A, B, and C of LBRV-PV and Rotasiil® in 1:1:1:1 ratio. Three doses of study vaccines were given at 6, 10, and 14 weeks of age. Blood samples were collected four weeks after the third dose to assess rotavirus IgA antibody levels. Non-inferiority of LBRV-PV to Rotasiil was proven if the lower limit two-sided 95% confidence interval (CI) of geometric mean concentration (GMC) ratio was at least 0.5. Lot-to-lot consistency was proven if 95% CI of the GMC ratios of three lots were between 0.5 and 2. Solicited reactions were collected by using diary cards.Of the 1500 randomized infants, 1436 infants completed the study. The IgA GMC ratio of LBRV-PV to Rotasiil® was 1.19 (95% CI 0.96, 1.48). The corresponding IgA seropositivity rates were 60.41% (57.41, 63.35) and 52.75% (47.48, 57.97). The IgA GMC ratios among the three LBRV-PV lots were: Lot A versus Lot B: 1.34 (1.03, 1.75); Lot A versus Lot C: 1.22 (0.93, 1.60); and Lot B versus Lot C: 0.91 (0.69, 1.19). The 95% CIs for the GMC ratios were between 0.69 and 1.75. The incidence of solicited reactions was comparable across the four arms. Only one serious adverse event of gastroenteritis event in the Rotasiil® group was causally related.The immunological non-inferiority of LBRV-PV against Rotasiil® as well as lot-to-lot consistency of LBRV-PV was demonstrated. LBRV-PV had safety profile similar to Rotasiil®.Clinical Trials.Gov [NCT03474055] and Clinical Trial Registry of India [CTRI/2017/10/010104].

Background: Diarrhea is one of the important causes of morbidity and mortality among under-five children in India. Lack of knowledge of mothers about the management of diarrheal diseases is a common problem in many developing countries. Use of oral rehydration solution (ORS) largely depends, on the level of mother’s knowledge. Objective: The objective of the study was to assess the knowledge of the mothers, from rural migrant population regarding the use of ORS in under-five children with diarrhea. Materials and Methods: A cross-sectional study was carried out from December 2016 to March 2017, among mothers of the migrant population residing and working at brick kilns and construction site in the field practice area of the rural health training center, Lavale, Pune. We included the mothers whose children were under five years of age. Those mothers, who had serious illness and had hearing and speech problems, were excluded from the study. Data were collected by interview method from mothers with the help of a pre-structured and pre-tested questionnaire. Results: A total of 54 (93.1%) mothers from brick kiln sites were included among whom, 43.10% were aware of ORS. Only 37.93% of mothers knew the use of homemade sugar salt solution for diarrhea in children. In this study, 25 (43.10%) mothers were illiterate and the study showed that knowledge regarding ORS was lower in illiterate mothers. Conclusion: Majority of the mothers were not aware regarding ORS, and as per the study, knowledge regarding ORS was lower in less educated mothers. Government schemes would help these mothers to increase the awareness which will result in a decrease in mortality rate.

Introduction: This is the first study in Indian paediatric subjects to evaluate the novel Measles, Mumps and Rubella (MMR) vaccine developed by M/s Cadila Healthcare Limited, India, containing the Hoshino mumps strain. This phase II study was done as part of clinical development programme to evaluate the safety and immunogenicity of the novel vaccine in small cohort of target population before conducting the larger comparative phase III study. Aim: To evaluate the immunogenicity and safety of the singledose and multi-dose formulations of the novel vaccine. Materials and Methods: One hundred and twenty three healthy children 15-18 months of age were administered a single dose of the novel MMR vaccine from either the single-dose or the multi-dose formulation. Immunogenicity of the vaccine was assessed by measuring IgG antibodies against the measles, mumps and rubella viruses before and six weeks after the vaccination. Safety of the vaccine was assessed by recording adverse events during the six week study period. Results: The seroconversion rate for anti-measles and antimumps antibodies was 100% while that for anti-rubella antibodies was 98.9% after the MMR vaccination. There was no difference in the seroconversion rates in the subjects receiving the MMR vaccine either from the single-dose or the multi-dose formulation. The Geometric Mean Titre (GMT) of anti-measles, anti-mumps and anti-rubella antibodies was 3154.0 mIU/mL, 90.6 EU/mL and 141.7 IU/mL, respectively. The vaccine was well tolerated, 28 subjects (out of 123) reported 43 adverse events during the study (adverse event rate of 21.8%). The most common adverse event reported during the study was fever in 19 subjects (15.4%) followed by rash and rhinorrhoea in five subjects (4.1%) each. Conclusion: The results of this phase II clinical trial show that both the single-dose and the multi-dose formulation of the novel MMR vaccine are immunogenic and well tolerated by healthy paediatric subjects aged 15-18 months.