Rotarix (rotavirus vaccine) / GSK - LARVOL DELTA

Antibody-mediated intracellular neutralization as a correlate of risk for rotavirus gastroenteritis in vaccinated infants (IMMUNOLOGY 2026) - "This intracellular neutralization assay captures a previously unmeasured component of antibody-mediated protection against rotavirus. We have demonstrated its value as a correlate of risk for rotavirus gastroenteritis in vaccinated human infants, and future work will evaluate its wider role as a correlate of protection."

Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Whole-Genome Characterization of Rare Artiodactyl-Like G10P [14] and G8P [14] Rotavirus a Strains Detected in Pediatric Gastroenteritis Cases in Hokkaido Prefecture, Japan. (PubMed, J Med Virol) - "Comparative amino acid analysis of VP4 between the To22-1/G8P[14] strain and the P[8] Rotarix vaccine strain revealed substitutions at 18 of 37 (48.6%) known antigenic epitope sites, suggesting a potential antigenic mismatch. Continued surveillance and further studies are warranted to elucidate the mechanisms underlying interspecies transmission of artiodactyl-like P[14] RVAs and to assess the effectiveness of current vaccines against such strains."

Journal • Gastroenterology • Gastrointestinal Disorder • Pediatrics • Rotavirus Infections

Low uptake rotavirus vaccine: A study of vaccine effectiveness against rotavirus-related hospitalization based on electronic health records, Slovenia, 2019-2023. (PubMed, Vaccine) - "Both full and partial rotavirus vaccination significantly reduced rotavirus-related hospitalizations among children in Slovenia. These findings support efforts to improve vaccine uptake and consideration of rotavirus vaccination inclusion in the NVP to reduce disease burden."

Journal • Rotavirus Infections

Childhood mortality from acute diarrheal disease in Paraguay and vaccination impact: a 31-year ecological study. (PubMed, Epidemiol Health) - "Paraguay has sustained declines in infant and childhood mortality over 3 decades through improvements in healthcare and immunization, with the 2010 introduction of Rotarix reducing the mortality rate by 43 deaths per 100,000 infants under 12 months. These results underscore the impact of vaccination and health system strengthening, while highlighting the need to monitor emerging threats."

Journal • Pediatrics • Rotavirus Infections

Study of Mixed Vaccination Schedules With a 21-valent Pneumococcal Conjugate Vaccine and a 20-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (clinicaltrials.gov) - P3 | N=580 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Pneumococcal Infections

Prevalence and molecular epidemiology of rotavirus gastroenteritis among children in Nairobi's urban informal settlements following introduction of the Rotavac® vaccine. (PubMed, Trop Med Health) - "Rotavirus remains a significant cause of gastroenteritis among children in Nairobi's urban informal settlements. The circulation of diverse and emerging strains underscores the need for continued molecular surveillance to monitor vaccine performance and guide future immunization strategies."

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

Safety and Immunogenicity of an Investigational Pentavalent Meningococcal ABCYW Vaccine Against Meningococcal Disease in Children, Toddlers, and Infants (clinicaltrials.gov) - P1/2 | N=750 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Meningococcal Infections • Pediatrics

Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age (clinicaltrials.gov) - P3 | N=896 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pneumococcal Infections

Effectiveness of Monovalent Rotavirus Vaccine (RV1) (clinicaltrials.gov) - P=N/A | N=362 | Completed | Sponsor: Children's Hospital Medical Center, Cincinnati | N=2268 ➔ 362

Enrollment change • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Examination of In Vivo Mutations in VP4 (VP8*) of the Rotarix® Vaccine from Shedding of Children Living in the Amazon Region. (PubMed, Viruses) - "A total of 11.4% (18/158) of children with Rotarix® G1P[8] shedding were unvaccinated, indicating the occurrence of indirect protection. Stability evidence of Rotarix® VP4 (VP8*) spike protein from samples collected in vivo is presented."

Journal • Preclinical • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Different Fc scaffolds enhance the breadth of in vitro neutralization of the same Fab against different Rotavirus strains. (PubMed, Front Immunol) - "These data suggest that scaffolds impact the ability of antibodies to neutralize rotavirus. These findings can assist vaccine design informing the use of different technologies or adjuvants to elicit more effective antibody classes and subclasses."

Journal • Preclinical • Infectious Disease • Rotavirus Infections

Lot-to-lot Consistency Study of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From 2 Months of Age (clinicaltrials.gov) - P3 | N=896 | Not yet recruiting | Sponsor: Sanofi

New P3 trial • Infectious Disease • Pneumococcal Infections

Genomic and Antigenic Analysis of G1P[8] Rotavirus Strains in Ningxia, China. (PubMed, Int J Infect Dis) - "This study confirms that G1P[8] RVA prevalence in Ningxia remains low; however, novel variants arising from reassortment may still emerge locally, accompanied by changes in antigenicity and genetic background. Sustained genotype surveillance and whole-genome analysis of RVA are essential for tracking epidemiological trends, evaluating vaccine effectiveness, and informing prevention and control strategies."

Journal • Rotavirus Infections • SPECC1

Quantifying the impact of switching from Rotarix to Rotavac rotavirus vaccine in Ghana. (PubMed, J Infect Dis) - "Our model offers a robust tool to support policymakers in Ghana and similar settings by evaluating current rotavirus vaccine effectiveness, guiding vaccine switching decisions, and informing introduction strategies in countries yet to adopt immunization."

Journal • Rotavirus Infections

Safety, immunogenicity, and relative efficacy of a parenteral trivalent rotavirus subunit vaccine candidate (TV P2-VP8) in healthy Ghanaian, Malawian, and Zambian infants. (PubMed, Vaccine) - P3 | "TV P2-VP8 provided inferior protection against SRVGE compared to ROTARIX. The vaccine candidate was safe, immunogenic, and well-tolerated by infants. Continued efforts are needed to identify alternative rotavirus vaccines with improved efficacy in LMICs."

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

Cost-Effectiveness Analysis of Universal Rotavirus Vaccination Schedules in Syria. (PubMed, Vaccines (Basel)) - " A decision tree model was developed to assess the cost-saving of two-dose rotavirus vaccinations (Rotarix®) compared to no vaccination... Introducing rotavirus vaccination is highly cost-saving and will result in a substantial reduction in healthcare burdens and lives lost. Policy planners must ensure its inclusion in the National Immunization Programs, ensuring sustainable financing and equitable access."

HEOR • 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

Complex evolutionary dynamics including reassortment drive genome diversity in human rotavirus species a circulating in Ireland. (PubMed, Infect Genet Evol) - "Notably, these strains show dissimilarity in the antigenic epitopes of the VP4 protein compared to the Rotarix vaccine...Our study supports using a viral metagenomic approach for RVA genetic characterisation to determine pathogen diversity and reassortments. The public health implications of the identified reassortant RVA strains, requires investigations for any potential impacts on vaccine efficacies."

Journal • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Whole-genome analysis of rotavirus G1P[8] and other Wa-like strains in Mozambican children: evidence of genetic variations of pre-vaccine G1P[8] strains from Manhiça, Mozambique. (PubMed, Microb Genom) - "The Rotarix® (GlaxoSmithKline, Rixenstart, Belgium) vaccine was adopted into the Expanded Program on Immunization in Mozambique in September 2015, and G1P[8] strains were frequent pre- and post-vaccine introduction in some regions of the country...Our results suggest that host factors are implicated in the inducement and severity of diarrhoea and these factors need further investigation. The changes in some G1 strains at the epitope region emphasize the need for continued whole-genome analysis, as substitutions in this region are reported to affect protein conformation at given positions and the study results may provide data for future studies aiming to understand rotavirus strain evolution post-vaccine introduction."

Journal • Rotavirus Infections

Pathogen-Focused Metagenomic Analysis of Pediatric Diarrheal Cases among Children under Five in Zambia Reveals Predominance of Human Rotavirus Genotypes G3 and G12 (ASTMH 2025) - "VP7 analysis revealed the presence of genotypes G1, G2, G3, G8, G9, and G12, which mostly clustered with global reference strains, while VP4 analysis identified P[4], P[6], P[8], and P[11] genotypes that form clades with vaccine strains (Rotarix & Rotavac) and wild-type lineages. Importantly, fully vaccinated children experienced milder disease compared to partially vaccinated or unvaccinated children (p = 0.002).This study demonstrates the significant value of VCS in genomic surveillance of vaccine-preventable diseases. It enables high-resolution detection of viral genotypes, reassortants, and antigenic variants, thereby facilitating real-time monitoring of viral evolution and guiding adaptive immunization programs and public health responses."

Clinical • Genomic analysis • Omic analysis • Pediatrics • Rotavirus Infections

Rotavirus A genotype diversity and antigenic profile in Central Ethiopia: implications for rotarix® vaccine efficacy. (PubMed, Front Microbiol) - "The dominance of the G9P[4] genotype, together with substantial amino acid substitutions in the current circulating RVA strains that diverge from the G1P[8] Rotarix® strain, may compromise vaccine performance. These findings underscore the need to evaluate vaccine efficacy, maintain molecular surveillance, and incorporate broader genotype coverage in future vaccine design."

Journal • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Australian Rotavirus Surveillance Program: Annual Report, 2024. (PubMed, Commun Dis Intell (2018)) - "Of the 1,880 samples confirmed rotavirus positive, 1,610 (85.6%) were identified as wildtype rotavirus; 268 (14.3%) were identified as the Rotarix vaccine-like strain; and two G1P[8] samples could not be confirmed as wildtype or vaccine-like due to inadequate sequence quality...Understanding the diversity of genotypes in circulation, and the emergence of variants, provides important context for any changes observed in disease epidemiology in the community. The Australian Rotavirus Surveillance Program provides diagnostic laboratories with valuable feedback on laboratory data quality, by reporting incidences of wildtype, vaccine-like, and/or false positive rotavirus results."

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

Genomic Analysis of Rotavirus G8P[8] Strains Detected in the United States Through Active Surveillance, 2016-2017. (PubMed, Viruses) - "During the 2016-2017 rotavirus surveillance season, the New Vaccine Surveillance Network (NVSN) identified 36 G8P[8] rotavirus strains across four sites in the U.S. This study presents the whole-genome characterization of these G8P[8] strains, along with comparative sequence analyses against the current vaccine strains, Rotarix and RotaTeq. Clinical analysis revealed no significant differences in hospitalization rates, length of stay, or severity scores between G8P[8] RVA-positive and non-G8P[8] RVA-positive subjects. Additionally, phylodynamic analysis determined the evolutionary rates and the most recent common ancestor for these strains, highlighting the importance of ongoing monitoring of rotavirus genotypes to assess the spread of these emerging G8P[8] strains."

Journal • Infectious Disease • Rotavirus Infections

Rotavirus Genotype Dynamics and the Emergence of G3P[8] in Thailand Following Nationwide Vaccine Implementation. (PubMed, Int J Mol Sci) - "The introduction of two live-attenuated oral vaccines, Rotarix and RotaTeq, has significantly decreased illness and death associated with rotavirus in countries where they are included in childhood immunization schedules. This study demonstrated a significant decline in the prevalence of rotavirus A infection in pediatric patients in Chiang Mai, Thailand, during the post-vaccination period. The findings from this study contribute to a better understanding of rotavirus epidemiology in Thailand following the implementation of the rotavirus vaccines."

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