Rotasiil (rotavirus vaccine, live attenuated (oral)) / Serum Institute of India - LARVOL DELTA

Infant Malaria Vaccine Schedule Optimization (clinicaltrials.gov) - P2 | N=975 | Active, not recruiting | Sponsor: PATH | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Malaria

Assessing the Impact of Rotavirus Vaccination in Iranian Children Under Five: An Agent-Based Modelling Approach. (PubMed, Health Sci Rep) - "Rotasiil is expected to substantially reduce rotavirus burden in Iran, lowering incidence, symptomatic days, and epidemic peak size. These results support the inclusion of rotavirus vaccination as a key child health intervention, though continued post-introduction surveillance remains essential."

Journal • Infectious Disease • Rotavirus Infections

Infant Malaria Vaccine Schedule Optimization (clinicaltrials.gov) - P2 | N=964 | Recruiting | Sponsor: PATH | Trial completion date: Mar 2028 ➔ Sep 2027 | Trial primary completion date: Mar 2028 ➔ Sep 2027

Trial completion date • Trial primary completion date • Infectious Disease • Malaria

Molecular epidemiology of rotavirus causing diarrhea among under-five children after the introduction of rotavirus vaccines, Rotavac and Rotasiil, into the national immunization program of India. (PubMed, Virol J) - "Rotavirus vaccination significantly reduced disease burden among under-five children in India. G3P[8] remained consistently dominant across regions, vaccine types, and years. Regional and vaccine-specific differences were evident, but trends suggest natural viral evolution may outweigh vaccine-driven selection. Sustained surveillance is essential to detect emerging strains and ensure long-term vaccine effectiveness."

Journal • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Rotavirus Infections

Strengthening Immunization Through Evidence: Lessons from ROTASIIL Implementation. (PubMed, Indian J Pediatr) - No abstract available

Journal

Sociodemographic and Clinical Characteristics of Rotavirus Diarrhea in Children Aged Under 5 Years in Odisha After the Introduction of Rotavirus Vaccine: A Hospital-Based Surveillance Study. (PubMed, Indian J Pediatr) - "Rotavirus remains an important cause of AGE in children aged under 5 y in Odisha, despite the introduction of rotavirus vaccination. The rotavirus positivity rate was lower than that reported in previous studies, suggesting a positive effect of vaccination. High vaccination coverage, addressing poverty, and prompt clinical management are essential to mitigate the impact of rotavirus diarrhea in Odisha."

Journal • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

An impact and cost-effectiveness analysis of rotavirus vaccine introduction in Egypt. (PubMed, Vaccine) - "Rotavirus vaccination could prevent a substantial number of RVGE cases, visits, hospitalizations and deaths in children. To be considered a cost-effective use of government health spending, the vaccine price would need to be reduced and/or lower health system delivery cost assumptions would need to be justified."

HEOR • Journal • Gastroenterology • Gastrointestinal Disorder • Psychiatry • Rotavirus Infections

Nutritional Status and Its Association with Rotavirus Diarrhea Among Children Aged Under 5 Years in Maharashtra, India. (PubMed, Indian J Pediatr) - "Overall, nutritional status was not associated with diarrhea severity. However, among vaccinated children, the risk of severe diarrhea was significantly lower in malnourished children than in non-malnourished children."

Journal • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Factors Associated with Rotavirus Positivity in Children with Acute Gastroenteritis in Jharkhand, India (2019-2023). (PubMed, Indian J Pediatr) - "Rotavirus remains an important cause of gastroenteritis in children aged under 5 y, particularly in infants, despite the availability of rotavirus vaccination. Declining rotavirus positivity in children with AGE and changes in the distribution of rotavirus genotypes during the study period may be attributable to the effects of vaccination."

Journal • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Rotasiil vaccine effectiveness against rotavirus-associated hospitalizations in the Democratic Republic of the Congo: comparison of multivariate logistic regression and inverse probability treatment weighting methods in a test-negative design. (PubMed, Vaccine) - "Rotasiil vaccination under conditions of routine use effectively reduces rotavirus-associated diarrhea hospitalizations among children, supporting the ongoing use of rotavirus vaccine. The IPTW VE estimate was more precise than multivariate logistic regression but the confidence intervals overlapped, suggesting that the resulting VE estimates are not statistically different and the methods are complementary."

Journal • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Rotavirus Infections

Epidemiology and Management of Intussusception Among Children Aged Under 2 Years in Gujarat, India. (PubMed, Indian J Pediatr) - "Ongoing surveillance is needed to establish whether vaccination with the oral pentavalent rotavirus vaccine, ROTASIIL, is associated with an increased risk of IS. Early case detection and referral, and increased use of safe and non-surgical methods of treatment need to be encouraged."

Journal • Pain • Rotavirus Infections

Genotype Diversity of Rotavirus in Odisha, India: Postvaccine Changes. (PubMed, Indian J Pediatr) - "The introduction of rotavirus vaccines has reduced the prevalence of rotavirus infections and altered the rotavirus genotype distribution in Odisha. The predominance of G3P[8] and resurgence of G2P[4] indicate evolving strain dynamics after vaccine introduction. This study, thus, highlights the importance of vaccination programs in mitigating rotavirus-associated morbidity, emphasizing the need for sustained monitoring to guide future vaccine strategies."

Journal • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Rotavirus Infections

Epidemiology and Clinical Profile of Rotavirus Diarrhea in Children Aged Under 5 Years in Kerala, India After the Introduction of Rotavirus Vaccination: A Surveillance Study. (PubMed, Indian J Pediatr) - "In children hospitalized with acute diarrhea, the prevalence of rotavirus was lesser among vaccinated than unvaccinated children. Monitoring of age shift, breakthrough infections in vaccinated children, and genotypic surveillance of emerging rotavirus genotypes are required to inform the development of next-generation vaccines."

Journal • Infectious Disease • Rotavirus Infections

Epidemiology of Rotavirus Gastroenteritis and Circulating Genotypes Among Hospitalized Children Aged Under 5 Years in Rajkot, Gujarat. (PubMed, Indian J Pediatr) - "Rotavirus diarrhea remains prevalent among children hospitalized with acute gastroenteritis in Rajkot. G3P[8] and G2P[4] are the predominant circulating rotavirus strains."

Journal • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Clinico-Epidemiological Profile of Intussusception Among Children Younger than 2 Years in Karnataka, India: A Multicenter Hospital-based Surveillance Study. (PubMed, Indian J Pediatr) - No abstract available

Journal • Rotavirus Infections

Infant Malaria Vaccine Schedule Optimization (clinicaltrials.gov) - P2 | N=1200 | Recruiting | Sponsor: PATH | Trial completion date: Nov 2027 ➔ Mar 2028 | Trial primary completion date: Nov 2027 ➔ Mar 2028

Trial completion date • Trial primary completion date • Infectious Disease • Malaria

Cost-effectiveness and benefit-risk of rotavirus vaccination in Afghanistan: a modelling analysis informed by post-licensure surveillance. (PubMed, BMC Health Serv Res) - "Our study supports the sustained use of rotavirus vaccination in Afghanistan. The health benefits of the vaccine greatly exceed the potential risks."

Benefit-risk assessment • HEOR • Journal • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Infant Malaria Vaccine Schedule Optimization (clinicaltrials.gov) - P2 | N=1200 | Recruiting | Sponsor: PATH | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Malaria

Infant Malaria Vaccine Schedule Optimization (clinicaltrials.gov) - P2 | N=1200 | Not yet recruiting | Sponsor: PATH

New P2 trial • Infectious Disease • Malaria

The Vaccine Godmother: Dr. Gagandeep Kang's Pioneering Journey in Global Health and Vaccine Development. (PubMed, Cureus) - "Over the course of her distinguished career, she has led groundbreaking research on rotavirus, contributing to the development of two WHO-approved vaccines tailored for Indian communities: Rotavac (Bharat Biotech, Hyderabad, India) and Rotasiil (Serum Institute of India, Pune, India). Dr. Kang's career exemplifies her dedication to advancing public health, vaccine development, and global health initiatives, making her a trailblazer in the field of microbiology and virology."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Novel Coronavirus Disease • Rotavirus Infections

Circulating rotavirus strains in children with acute gastroenteritis in Iran, 1986 to 2023 and their genetic/antigenic divergence compared to approved vaccines strains (Rotarix, RotaTeq, ROTAVAC, ROTASIIL) before mass vaccination: Clues for vaccination policy makers. (PubMed, Virus Res) - "However, considering the rotavirus genotypic pattern, ROTAVAC might not be a good choice for Iran. Overall, the findings of this study provide valuable insights into the prevalence of rotavirus strains and the potential effectiveness of different vaccines in the Iranian and similar populations."

Journal • Review • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Rotavirus Infections

Effect of Non-Rotavirus Enteric Infections on Vaccine Efficacy in a ROTASIIL Clinical Trial. (PubMed, Am J Trop Med Hyg) - "Rotavirus continued to be the leading cause of severe GE in this age group. The adjusted VE estimates obtained did not support co-infections as a major cause of lower vaccine performance in low- and middle-income countries."

Journal • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Rotavirus Infections

Rotavirus and adenovirus infections in children with acute gastroenteritis after introducing the Rotasiil® vaccine in Kisangani, Democratic Republic of the Congo. (PubMed, PLoS One) - "The prevalence of rotavirus infection remains high in Kisangani despite vaccination. However, the prevalence of adenovirus infections was low in our series. Complete vaccination with three doses and mothers' average and high level of knowledge about the rotavirus vaccine significantly reduces the rate of rotavirus infection. It is, therefore, essential to strengthen the mothers' health education, continue with the Rotasiil® vaccine, and ensure epidemiological surveillance of rotavirus infection."

Journal • Gastroenterology • Gastrointestinal Disorder • Infectious Disease • Rotavirus Infections

Post-marketing safety surveillance of the rotavirus vaccine in India. (PubMed, Vaccine ) - "ROTASIIL, an oral live attenuated bovine-human reassortant pentavalent rotavirus vaccine, was approved in 2017...No safety concerns were reported. The study was funded by SIIPL which is the manufacturer of the study product."

Journal • P4 data • Musculoskeletal Diseases • Orthopedics • Otorhinolaryngology • Rotavirus Infections

Impact of vaccination with different types of rotavirus vaccines on the incidence of intussusception: a randomized controlled meta-analysis. (PubMed, Front Pediatr) - "Subgroup analysis for different vaccine brands and types (RV1 (Rotarix, Rotavac, RV3-BB), RV3 (LLR3), RV5 (RotasiiL, RotaTeq), and RV6) showed no significant variation in intussusception incidence. Given the substantial benefits outweighing the risks, promoting the use of newly developed rotavirus vaccines remains highly valuable. www.crd.york.ac.uk/prospero/, Identifier CRD42023425279."

Journal • Retrospective data • Review • Pain • Pediatrics • Rotavirus Infections