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

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

Diverse processes in rotavirus vaccine development. (PubMed, Hum Vaccin Immunother) - "While two widely used vaccines, Rotarix and RotaTeq, have shown good efficacy in high-income countries, their effectiveness is lower in low- and middle-income countries due to factors such as malnutrition and poor sanitation.4-6 These challenges include complex vaccination schedules and high production costs. Researchers are working on novel vaccines, including inactivated virus and viral protein-based options, as well as virus-like particles and recombinant proteins.7-9 Improving vaccine stability and applicability is crucial for resource-limited settings, and global vaccination strategies are expected to significantly reduce infection burdens, improve child health, and contribute to the achievement of global health goals.10-14."

Journal • Review • Infectious Disease • 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 | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pneumococcal 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=2320 | Recruiting | Sponsor: Sanofi | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pneumococcal 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=2320 | Not yet recruiting | Sponsor: Sanofi

New P3 trial • 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 | Not yet recruiting | Sponsor: Sanofi

New P3 trial • Infectious Disease • Pneumococcal Infections

Rotavirus vaccine effectiveness and coverage among children younger than 5 years old in Shanghai, China: A test-negative case control study. (PubMed, Vaccine) - "RotaTeq demonstrates a robust protective effectiveness, while LLR provides a certain level of protection against mild to moderate rotavirus diarrhea in children in Shanghai. For privately purchased (non-NIP) vaccines, we estimate that the coverage for rotavirus vaccines among children in Shanghai is high. Complete rotavirus vaccination is recommended for age-eligible children. Further post-marketing research on rotavirus vaccines is necessary to inform decision-making regarding the introduction of rotavirus vaccination in China."

Journal • Rotavirus Infections

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

Enrollment closed • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections

Epidemiological, molecular, and evolutionary characteristics of G1P[8] rotavirus in China on the eve of RotaTeq application. (PubMed, Front Cell Infect Microbiol) - "Phylogenetic and neutralizing epitope analysis showed that Rotavin-M1 might have better protection on G1P[8] prevalent in China than Rotarix and RotaTeq. Identity and phylogeny analysis showed that Chinese G1P[8] from before 2018 was generally stable with possible genetic recombination among local strains. These findings not only are of great significance for predicting the prevalence of G1P [8] in China, but also provide data reference for evaluating rotavirus vaccine efficacy."

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=1630 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Pneumococcal 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=1630 | Not yet recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company

New P3 trial • 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 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Not yet recruiting ➔ Recruiting

Enrollment open • Infectious Disease • Meningococcal Infections • Pediatrics

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

New P1/2 trial • 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 | Recruiting | Sponsor: Sanofi Pasteur, a Sanofi Company | Trial completion date: Mar 2026 ➔ Sep 2025

Trial completion date • Pediatrics • Respiratory Diseases • Respiratory Syncytial Virus Infections