RotaTeq (Live attenuated pentavalent Rotavirus oral vaccine) / Merck (MSD) - LARVOL DELTA

Early-life gut microbiome composition and rotavirus vaccine-induced IgA responses in U.S. infants: a longitudinal cohort study. (PubMed, EBioMedicine) - "In a healthy U.S. infant cohort, early-life gut microbiome diversity and composition were associated with rotavirus-IgA responses following RotaTeq vaccination. This study advances understanding of microbiome-vaccine interactions in high-income settings."

Journal • 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

TYPE-SPECIFIC EFFECTIVENESS OF PENTAVALENT ROTAVIRUS VACCINE RV5 AMONG CHILDREN IN CHINA: ANALYSIS OF TEST-NEGATIVE CASE-CONTROL STUDY ACROSS 37 HOSPITALS AND 4 ROTAVIRUS SEASONS (2020-2025) (ESPID 2026) - "Conclusions/Learning Points In routine practice across China, RV5 provided high protection against hospital-treated RVGE caused by G2/G3/G4 and G1/G2/G3/G4/G9, supporting robust real-world effectiveness. These findings reinforce the value of RV5 in pediatric vaccination programs."

Clinical • Infectious Disease • 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

Does an off-label two-dose RotaTeq vaccine schedule translate into a higher incidence of rotavirus hospital admissions compared to the approved three-dose RotaTeq schedule? A Canadian immunization research network study. (PubMed, Vaccine) - "This study provides reassuring evidence regarding the use of a two-dose RotaTeq schedule in a high-income country with relatively high vaccination coverage and reaffirms the substantial impact of RV vaccination introduction at a population level."

Journal • Gastroenterology • Gastrointestinal Disorder • 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

Study of a 4-Dose Regimen of a 21-valent Pneumococcal Conjugate Vaccine in Healthy Infants From Approximately 2 Months of Age (clinicaltrials.gov) - P3 | N=1714 | Active, not recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Recruiting ➔ Active, not recruiting

Enrollment closed • Infectious Disease • Pneumococcal 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

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

CORAL: Co-administration Study of an Investigational Live-Attenuated Respiratory Syncytial Virus Vaccine in Infants and Toddlers (clinicaltrials.gov) - P3 | N=2226 | Terminated | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Terminated; Sponsor decision

Trial termination • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus 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 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pneumococcal Infections

MEQ00064: Study of a Quadrivalent Meningococcal Conjugate Vaccine (MenACYW Conjugate Vaccine) Given With Routine Pediatric Vaccines in Healthy Infants and Toddlers in India and the Republic of South Africa (clinicaltrials.gov) - P3 | N=1528 | Completed | Sponsor: Sanofi Pasteur, a Sanofi Company | Active, not recruiting ➔ Completed

Trial completion • 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 | Not yet recruiting | Sponsor: Sanofi

New P3 trial • Infectious Disease • Pneumococcal 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

Early-life gut microbiome is associated with immune response to the oral rotavirus vaccine in healthy infants in the US. (PubMed, medRxiv) - "This study investigates the development of the infant gut microbiome and its association with immunogenicity following RotaTeq administration in U.S. infants...This study contributes to a clearer understanding of microbiome-vaccine interactions, particularly in high-income settings where existing evidence has been limited. Office of the Director of the National Institutes of Health, National Institute of Mental Health of the National Institutes of Health, and the National Center for Advancing Translational Sciences of the National Institutes of Health."

Journal • 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

Intussusception risk after rotavirus vaccination in Korean infants. (PubMed, Vaccine) - "The risk of intussusception increased within 7 days after the first dose of Rotarix vaccination, while no significant evidence of an increased risk was observed after RotaTeq vaccination."

Journal • Rotavirus Infections

Unveiling a Shift in the Rotavirus Strains in Benin: Emergence of Reassortment Intergenogroup and Equine-like G3P[8] Strains in the Post-Vaccination Era. (PubMed, Viruses) - "In the P[8] gene, three conservative (N195G, N195D, N113D) and one radical (D133N) substitutions were observed when compared with vaccine strains Rotarix and RotaTeq. These findings suggest continuous viral evolution, potentially driven by vaccine pressure. Ongoing genomic surveillance is essential to monitor genotype shifts as part of the efforts to evaluate the impact of emerging strains and to assess vaccine effectiveness in Sub-Saharan Africa."

Journal • 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 | Recruiting | Sponsor: Sanofi | Trial completion date: May 2027 ➔ Aug 2027 | Trial primary completion date: May 2027 ➔ Aug 2027

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

VISUALIZATION OF THE IMPACT OF ROTAVIRUS VACCINATION IN FINLAND (ESPID 2025) - "Background In 2009, Finland introduced a multivalent rotavirus vaccine (RotaTeq TM , RV5) in its national immunization program (NIP)...Conclusions/Learning Points We created a web-based tool to illustrate the impact of rotavirus vaccination on RVGE in children 0-7 years, for the first time analyzing AGE/UGE/RVGE incidence until 2021. The visualization highlights the impact of the NIP at both the national and regional levels, and the need to maintain high VCRs to sustain program impact."

Rotavirus Infections

Disease burden of rotavirus related diarrhea in children under 5 years in China: a meta-analysis. (PubMed, Sci Rep) - "Notably, the RV positivity rate declined from 27.3 to 21.5% pre- and post- the RotaTeq® licensure and 28.8-22.5% following the COVID-19 pandemic. The G9P[8] genotype was predominant, accounting for 71.7% of the RV cases in the under-5 age group. Given the dynamic nature of the incidence rate of RV-related diarrhea and the prevalence of the G9P[8] genotype, it is imperative to enhance surveillance efforts targeting incidence of RV-related diarrhea and the circulating genotypes of rotavirus."

Journal • Retrospective data • Infectious Disease • Novel Coronavirus Disease • Rotavirus Infections

Genetic and Antigenic Variability in VP4 and VP7 of Group A Human Rotavirus in Yunnan, China from 2015-2020. (PubMed, Intervirology) - "Our study shows that G9P [8] is the most dominant rotavirus genotype in Yunnan China. Consistent with the recent epidemic trend of RV strains in China, this study could provide new perspectives on vaccine research."

Journal • Rotavirus Infections

Emergence of Equine-like G3P[8] Rotavirus Strains Infecting Children in Venezuela. (PubMed, Viruses) - "The novel G3P[8]s carry amino acid changes in VP7-neutralizing epitopes, compared with the RotaTeq-WI78-8-vaccine strain. Full genome sequencing of a representative strain revealed a genotype constellation including an equine-like G3P[8] in a DS-1-like backbone (I2-R2-C2-M2-A2-N2-T2-E2-H2), confirming the role of animal strains as a source of diversification, and the importance of unceasingly revising molecular typing strategies and vaccine efficacy to guarantee their success."

Journal • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections

Whole-Genome Analysis of G2P[4] Rotavirus Strains in China in 2022 and Comparison of Their Antigenic Epitopes with Vaccine Strains. (PubMed, Viruses) - "High genetic variability among the newly characterized G2P[4] RVA strains suggest the strains evolve fast. Finally, our data suggest that the multivalent RotaTeq vaccine could have provided better protection than the monovalent Rotarix and LLR."

Clinical • Journal • Gastroenterology • Gastrointestinal Disorder • Rotavirus Infections