Rotarix (rotavirus vaccine) / GSK - LARVOL DELTA

Impact of the introduction of the rotavirus vaccine on the trend of diarrhoeal cases among children aged 0–4 years in Maputo City (2016–2025) (AIDS 2026) - "These results reinforce the importance of maintaining high vaccination coverage, strengthening continuous epidemiological surveillance, and promoting complementary hygiene and sanitation measures."

Clinical • Infectious Disease • Rotavirus Infections

Randomized controlled trial evaluating immunogenicity and safety of a porcine circovirus-free rotavirus vaccine in healthy Chinese infants. (PubMed, Hum Vaccin Immunother) - P3 | "Rotarix PCV-free demonstrated non-inferior SCRs vs Rotarix. Both vaccines showed comparable safety profiles.ChinaDrugTrials.org registration: CTR2023189.EudraCT: 2020-000972-38."

Clinical • Journal • Preclinical • Cough • Respiratory Diseases • Rotavirus Infections

Epidemiology and Clinical Impact of Pediatric Viral Gastroenteritis Before and After Rotavirus Vaccination in Sicily. (PubMed, Pathogens) - "Compared with the pre-vaccine era, rotavirus prevalence declined (32.6% vs. 13.3%), seasonal patterns were attenuated and genotype distribution shifted toward G2P[4], G9P[8] and equine-like G3P[8] strains. Despite the decline in RV-AGE following vaccine introduction, rotavirus remains a relevant cause of pediatric AGE, underscoring the need for high vaccination coverage and continued surveillance."

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

Clinical and genomic surveillance of rotavirus causing acute gastroenteritis in the community of Madrid, Spain, 2021-2023: predominance of equine-like G3 strains. (PubMed, Sci Rep) - "Spain has recently included rotavirus vaccines (RV1 [Rotarix] and RV5 [RotaTeq]) into the National Immunization Programme, following a period of exclusive private availability. Our findings reinforce the protective effect of full rotavirus vaccination in reducing hospitalizations, regardless of circulating genotypes. Nonetheless, given the observed genetic diversity and signals of reduced cross-protection of RV1 against EQL-G3 strains, continued and expanded molecular surveillance is essential to improve understanding of rotavirus diversity and to contextualize circulating genotypes within their clinical relevance over time."

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

ETIOLOGICAL AND DEMOGRAPHIC CHARACTERISTICS OF ACUTE VIRAL DIARRHEA IN A PEDIATRIC REFERENCE UNIT IN SERGIPE, BRAZIL (ESPID 2026) - "The highest incidences were recorded in Aracaju (n=39), Nossa Senhora do Socorro (n=13), and São Cristóvão (n=10). Conclusions/Learning Points The high prevalence of norovirus and rotavirus, with a predominance of the rotavirus genotype G3P8, a partially heterotypic genotype, when compared to the Rotarix® vaccine countrywide used in Brazil, which was less frequent in previous surveillance, confirms the need for continuous genomic surveillance to monitor regional viral dynamics."

Clinical • Infectious Disease • Novel Coronavirus Disease • Rotavirus Infections

Rota-Omics: How Gut Health Affects Immune Responses to the Oral Rotavirus Vaccine in Adults in Zambia (clinicaltrials.gov) - P=N/A | N=43 | Recruiting | Sponsor: Centre for Infectious Disease Research in Zambia

New trial • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Immune response to rotavirus vaccines in low- and middle-income countries: Challenges and perspectives. (PubMed, Hum Vaccin Immunother) - "In this review, we critically examine the immune responses elicited by natural rotavirus infection and by oral vaccination in both HICs and LMICs. The goal is to identify immunological factors associated with durable protection and to define key characteristics that an improved rotavirus vaccine should possess to achieve sustained high efficacy in LMICs."

Journal • Review • Infectious Disease • Rotavirus Infections

Cost-Effective Threshold Price for Alternative Infant and Neonatal Rotavirus Vaccines: A Dual-Country Evaluation. (PubMed, medRxiv) - "We aim to identify the conditions under which switching to RV3-BB is optimal in Malawi and Ghana, where the current immunization programs use 2-dose Rotarix and 3-dose Rotavac schedules, respectively. At moderate willingness-to-pay (∼0.5-time Gross Domestic Product per capita), RV3-BB was preferred over Rotavac if price per dose was <$1.2 in Malawi and <$2.5 in Ghana, and/or if the average duration of protection exceeded 40 weeks in Malawi. The RV3-BB vaccine is likely to be cost-effective in Malawi and Ghana, as well as other LMICs, based on expected pricing and duration of protection."

HEOR • Journal • Rotavirus Infections

Impact of Rotavirus Vaccine on Rotavirus Diarrhea-Associated Hospitalizations Among Children Under 5 Years of Age in Uganda. (PubMed, J Pediatric Infect Dis Soc) - "Declines were evident each year after Rotarix introduction and at each surveillance site, predominantly among infants. Continued monitoring for long-term impact is warranted given changes in the vaccine formulation in Uganda."

Journal • Rotavirus Infections

Study of the Safety of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (clinicaltrials.gov) - P3 | N=2360 | Active, not recruiting | Sponsor: Sanofi | Recruiting ➔ Active, not recruiting | Trial completion date: May 2027 ➔ Oct 2027 | Trial primary completion date: May 2027 ➔ Oct 2027

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Pneumococcal Infections

Effectiveness of monovalent rotavirus vaccine among young children in Pakistan: a test-negative case-control evaluation. (PubMed, Vaccine) - "2 RV1 doses appear to provide fair protection in this very high burden setting. Additional vaccination strategies should continue to be pursued for children in this and similar locations."

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

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

Molecular detection and characterization of rotavirus A in wastewater from Morogoro, Tanzania. (PubMed, J Water Health) - "Despite the introduction of the Rotarix® vaccine in 2013, rotavirus-associated morbidity remains high particularly in areas with poor sanitation...This study confirms the presence of rotavirus A G3P [8] genotypes in wastewater influent in Morogoro, Tanzania. The study highlights the utility of wastewater surveillance as a complementary tool for monitoring rotavirus circulation."

Journal • 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