A Phase II, Observer-blinded, Randomized, Active-controlled Study to Examine the Immunogenicity and Safety of Rotarix® and RV3-BB When Co-administered/Boosted With Trivalent P2-VP8 Subunit Rotavirus Vaccine Candidate in Healthy Infants in South Africa

The study will evaluate safety and immunogenicity of LORV (Rotarix and RV3-BB) when TV P2-VP8, a parentally administered rotavirus vaccine is administered either concomitantly or as a prime/boost model. Participants would be newborn babies or infants approximately at 6 weeks of age ta the time of enrollment. The vaccines will be administered at birth (only for one cohort) and at 6, 10 and 14 weeks. Immune response will be assessed prior to first vaccination, 14 weeks and at 18 weeks of age. The study will also evaluate the shedding of Rotarix virus after a challenge dose administered 28 days after last investigational product administration. Safety assessments will be conducted throughout the study duration.

开始日期2021-02-22

申办/合作机构

Program for Appropriate Technology in Health

[+4]

NCT04185545

/ Completed临床3期

Efficacy, Safety and Immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in Neonates, Lot to Lot Consistency and Antigen Interference With Co-Administered EPI Vaccines (Phase III)

This phase III trial aims to assess the efficacy, safety and immunogenicity of Rotavirus RV3 Vaccine (Bio Farma) in neonates, lot-to-lot consistency, and antigen interference with co-administered EPI vaccines

开始日期2020-10-30

申办/合作机构

PT Bio Farma

NCT03483116

/ Completed临床2期IIT

A Phase II Randomized, Double Blind, Parallel Group Dose-ranging Study of Oral RV3-BB Rotavirus Vaccine Administered at a High, Mid and Low Titre as a 3 Dose Neonate Schedule or Administered at a High Titre as a 3 Dose Infant Schedule.

The purpose of this study is to determine the serum IgA response of three dose levels of the oral RV3-BB vaccine when administered in a neonatal schedule or when administered as a high dose in an infant schedule.

开始日期2018-06-15

申办/合作机构

Murdoch Childrens Research Institute

100 项与 Rotavirus vaccine (Bio-Farma/Murdoch-Childrens-Research-Institute) 相关的临床结果

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100 项与 Rotavirus vaccine (Bio-Farma/Murdoch-Childrens-Research-Institute) 相关的转化医学

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100 项与 Rotavirus vaccine (Bio-Farma/Murdoch-Childrens-Research-Institute) 相关的专利（医药）

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项与 Rotavirus vaccine (Bio-Farma/Murdoch-Childrens-Research-Institute) 相关的文献（医药）

2022-11-30·Human vaccines & immunotherapeutics

Model-based estimation of the impact on rotavirus disease of RV3-BB vaccine administered in a neonatal or infant schedule

Article

作者: Jodie McVernon ; Nicholas Geard ; Julie E. Bines ; Nefel Tellioglu ; Vicka Oktaria ; Richard Bradhurst ; Amanda Handley

Rotavirus infection is a common cause of severe diarrheal disease and a major cause of deaths and hospitalizations among young children. Incidence of rotavirus has declined globally with increasing vaccine coverage. However, it remains a significant cause of morbidity and mortality in low-income countries where vaccine access is limited and efficacy is lower. The oral human neonatal vaccine RV3-BB can be safely administered earlier than other vaccines, and recent trials in Indonesia have demonstrated high efficacy. In this study, we use a stochastic individual-based model of rotavirus transmission and disease to estimate the anticipated population-level impact of RV3-BB following delivery according to either an infant (2, 4, 6 months) and neonatal (0, 2, 4 months) schedule. Using our model, which incorporated an age- and household-structured population and estimates of vaccine efficacy derived from trial data, we found both delivery schedules to be effective at reducing infection and disease. We estimated 95-96% reductions in infection and disease in children under 12 months of age when vaccine coverage is 85%. We also estimate high levels of indirect protection from vaccination, including 78% reductions in infection in adults over 17 years of age. Even for lower vaccine coverage of 55%, we estimate reductions of 84% in infection and disease in children under 12 months of age. While open questions remain about the drivers of observed lower efficacy in low-income settings, our model suggests RV3-BB could be effective at reducing infection and preventing disease in young infants at the population level.

2022-05-01·The Lancet. Infectious diseases1区 · 医学

Neonatal rotavirus vaccine (RV3-BB) immunogenicity and safety in a neonatal and infant administration schedule in Malawi: a randomised, double-blind, four-arm parallel group dose-ranging study

1区 · 医学

Article

作者: Rhian Bonnici ; Jonathan Mandolo ; Julie E Bines ; Karen Boniface ; Daniel Cowley ; Nada Bogandovic-Sakran ; Daniel Pavlic ; Celeste M Donato ; Frances Justice ; Ann Turner ; Darren Suryawijaya Ong ; Jim Ackland ; Naor Bar-Zeev ; Miren Iturriza-Gomara ; Desiree Witte ; Graeme Barnes ; Khuzwayo C Jere ; Ashley Mpakiza ; Amanda Handley ; Nigel A Cunliffe

BACKGROUND:

Rotavirus vaccines reduce rotavirus-related deaths and hospitalisations but are less effective in high child mortality countries. The human RV3-BB neonatal G3P[6] rotavirus vaccine administered in a neonatal schedule was efficacious in reducing severe rotavirus gastroenteritis in Indonesia but had not yet been evaluated in African infants.

METHODS:

We did a phase 2, randomised, double-blind, parallel group dose-ranging study of three doses of oral RV3-BB rotavirus vaccine in infants in three primary health centres in Blantyre, Malawi. Healthy infants less than 6 days of age with a birthweight 2·5 to 4·0 kg were randomly assigned (1:1:1:1) into one of four treatment groups: neonatal vaccine group, which included high-titre (1·0 × 10⁷ focus-forming unit [FFU] per mL), mid-titre (3·0 × 10⁶ FFU per mL), or low-titre (1·0 × 10⁶ FFU per mL); and infant vaccine group, which included high-titre (1·0 × 10⁷ FFU per mL) using a computer generated code (block size of four), stratified by birth (singleton vs multiple). Neonates received their three doses at 0-5 days to 10 weeks and infants at 6-14 weeks. Investigators, participant families, and laboratory staff were masked to group allocation. Anti-rotavirus IgA seroconversion and vaccine take (IgA seroconversion and stool shedding) were evaluated. Safety was assessed in all participants who received at least one dose of vaccine or placebo. The primary outcome was the cumulative IgA seroconversion 4 weeks after three doses of RV3-BB in the neonatal schedule in the high-titre, mid-titre, and low-titre groups in the per protocol population, with its 95% CI. With the high-titre group as the active control group, we did a non-inferiority analysis of the proportion of participants with IgA seroconversion in the mid-titre and low-titre groups, using a non-inferiority margin of less than 20%. This trial is registered at ClinicalTrials.gov (NCT03483116).

FINDINGS:

Between Sept 17, 2018, and Jan 27, 2020, 711 participants recruited were randomly assigned into four treatment groups (neonatal schedule high titre n=178, mid titre n=179, low titre n=175, or infant schedule high titre n=179). In the neonatal schedule, cumulative IgA seroconversion 4 weeks after three doses of RV3-BB was observed in 79 (57%) of 139 participants in the high-titre group, 80 (57%) of 141 participants in the mid-titre group, and 57 (41%) of 138 participants in the low-titre group and at 18 weeks in 100 (72%) of 139 participants in the high-titre group, 96 (67%) of 143 participants in the mid-titre group, and 86 (62%) of 138 of participants in the low-titre. No difference in cumulative IgA seroconversion 4 weeks after three doses of RV3-BB was observed between high-titre and mid-titre groups in the neonatal schedule (difference in response rate 0·001 [95%CI -0·115 to 0·117]), fulfilling the criteria for non-inferiority. In the infant schedule group 82 (59%) of 139 participants had a cumulative IgA seroconversion 4 weeks after three doses of RV3-BB at 18 weeks. Cumulative vaccine take was detected in 483 (85%) of 565 participants at 18 weeks. Three doses of RV3-BB were well tolerated with no difference in adverse events among treatment groups: 67 (39%) of 170 participants had at least one adverse event in the high titre group, 68 (40%) of 172 participants had at least one adverse event in the mid titre group, and 69 (41%) of 169 participants had at least one adverse event in the low titre group.

INTERPRETATION:

RV3-BB was well tolerated and immunogenic when co-administered with Expanded Programme on Immunisation vaccines in a neonatal or infant schedule. A lower titre (mid-titre) vaccine generated similar IgA seroconversion to the high-titre vaccine presenting an opportunity to enhance manufacturing capacity and reduce costs. Neonatal administration of the RV3-BB vaccine has the potential to improve protection against rotavirus disease in children in a high-child mortality country in Africa.

FUNDING:

Bill & Melinda Gates Foundation, Australian Tropical Medicine Commercialisation Grant.

2022-01-01·Biologicals : journal of the International Association of Biological Standardization4区 · 生物学

Modeling the long-term 2-8 °C stability profiles of a live, rotavirus vaccine candidate (RV3-BB) in various liquid formulations via extrapolations of real-time and accelerated stability data

4区 · 生物学

Article

作者: Volkin, David B ; Joshi, Sangeeta B ; Pullagurla, Swathi R ; Hamidi, Ahd ; Bines, Julie E ; Ogun, Oluwadara ; Kumru, Ozan S ; Hoeksema, Femke ; Kumar, Prashant ; Yallop, Christopher

To accelerate the formulation development of live-virus vaccine (LVV) candidates, more rapid approaches to rank-order formulations and estimate their real-time storage stability losses are needed. In this case-study, we utilize new and previously described stability data of a live, rotavirus vaccine candidate (RV3-BB) in three different liquid formulations to model and compare predicted vs. experimental RV3-BB stability profiles. Linear-regression extrapolations of limited real-time (2-8 °C) stability data and Arrhenius modeling of accelerated (15, 25, 37 °C) stability data provided predictions of RV3-BB real-time stability profiles (2-8 °C, 24 months). Good correlations of modeled versus experimental stability data to rank-order the RV3-BB formulations were achieved by employing (1) a high-throughput RT-qPCR assay to measure viral titers, (2) additional assay replicates and stability time-points, and (3) a -80 °C control for each formulation to benchmark results at each stability time-point and temperature. Instead of accumulating two-year, 2-8 °C storage stability data, the same rank-ordering of the three RV3-BB formulations could have been achieved by modeling 37°, 25°, 15° (and 2-8 °C) stability data over 1, 3 and 12 months, respectively. The results of this case-study are discussed in the context of accelerating LVV formulation development by expeditiously identifying stable formulations, estimating their shelf-lives, and determining vaccine vial monitoring (VVM) designations.

项与 Rotavirus vaccine (Bio-Farma/Murdoch-Childrens-Research-Institute) 相关的新闻（医药）

2026-09-08

·动脉网

通过Bio Farma与MCRI合作开发的新生儿轮状病毒疫苗Bio-RV获得印尼国家药品和食品监督管理局（BPOM）的市场营销授权Bio-RV, a Neonatal Rotavirus Vaccine Developed Through Bio Farma–MCRI Collaboration, Receives Marketing Authorization from BPOM

Jakarta (ANTARA) - PT Bio Farma (Persero), together with Murdoch Children’s Research Institute (MCRI), has marked an important milestone in efforts to strengthen the protection of children against rotavirus disease following the issuance of marketing authorization for Bio-RV, a neonatal rotavirus vaccine, by the Indonesian Food and Drug Authority (BPOM).. 雅加达（安塔拉通讯社）——印度尼西亚食品药品监督管理局（BPOM）批准新生儿轮状病毒疫苗Bio-RV的上市许可后，印尼国有制药公司PT Bio Farma（Persero）与默多克儿童研究所（MCRI）共同标志着在加强儿童免受轮状病毒疾病侵害的保护方面取得了重要里程碑。Bio Farma officially received marketing authorization for Bio-RV on September 2, 2026. This regulatory milestone follows an extensive journey encompassing research, process development, preclinical and clinical studies, technology transfer, regulatory submission, and manufacturing preparation involving various national and international institutions.. Bio Farma于2026年9月2日正式获得Bio-RV的上市许可。这一监管里程碑标志着历经广泛历程的成果，该历程涵盖研究、工艺开发、临床前和临床研究、技术转移、监管申报以及制造准备，涉及众多国内外机构。The marketing authorization confirms that Bio-RV has undergone BPOM’s evaluation of its safety, efficacy, and quality in accordance with applicable regulatory standards and requirements. For Bio Farma and MCRI, this achievement shows how collaboration among research institutions, academia, industry, and global partners can translate into biotechnology innovation with the potential to deliver tangible public health benefits.. 该上市许可确认，Bio-RV 已根据适用的监管标准和要求，通过了印度尼西亚食品药品监督管理局（BPOM）对其安全性、有效性和质量的评估。对于印尼生物法玛公司（Bio Farma）和月球城研究所以及合作伙伴而言，这一成就彰显了研究机构、学术界、产业界和全球伙伴之间的合作如何转化为具有带来切实公共卫生效益潜力的生物技术创新。Bio-RV is a naturally attenuated live rotavirus vaccine administered orally. The vaccine is intended to prevent gastroenteritis, or acute diarrhea, caused by rotavirus infection. It is administered in a three-dose schedule: the first dose at 0–5 days of age, the second at 8–10 weeks, and the third at 12–14 weeks. Bio-RV 是一种口服的自然减毒活轮状病毒疫苗。该疫苗旨在预防由轮状病毒感染引起的胃肠炎（即急性腹泻）。该疫苗采用三剂接种程序：第一剂在出生后 0–5 天接种，第二剂在 8–10 周龄接种，第三剂在 12–14 周龄接种。These characteristics allow vaccination to begin during the neonatal period, establishing protection against rotavirus disease from the earliest stage of an infant’s life, at a time when families are in contact with their local health services. 这些特性使得在新生儿期即可开始接种疫苗，从而在婴儿生命的最早阶段建立对轮状病毒疾病的防护，此时家庭正与当地卫生服务机构保持接触。Bio-RV is particularly relevant as rotavirus remains one of the leading causes of severe diarrhea among infants and young children. Citing data from the Indonesia Rotavirus Surveillance Network for 2001–2017, the Indonesian Ministry of Health reported that rotavirus accounted for approximately 41–58 percent of diarrhoeal cases among children under five requiring hospitalization. 轮状病毒疫苗（Bio-RV）尤其重要，因为轮状病毒仍然是导致婴儿和幼儿严重腹泻的主要原因之一。印度尼西亚卫生部引用2001–2017年印度尼西亚轮状病毒监测网络的数据报告称，在需要住院治疗的五岁以下儿童腹泻病例中，轮状病毒约占41%至58%。Recurrent diarrhea may also impair nutrient absorption and increase the risk of growth disorders in children.. 复发性腹泻还可能损害营养吸收，并增加儿童生长障碍的风险。Bio Farma President Director Shadiq Akasya said that obtaining marketing authorization for Bio-RV reflects the company’s commitment to delivering vaccine innovations that address public health needs while strengthening Indonesia’s national capabilities in vaccine development. Bio Farma 总裁董事 Shadiq Akasya 表示，获得 Bio-RV 的上市许可反映了公司致力于提供满足公共卫生需求的疫苗创新，同时加强印度尼西亚在疫苗开发方面的国家能力。“Bio-RV is not simply about introducing a new vaccine. Behind this achievement lies an extensive journey of scientific advancement, process development, preclinical and clinical studies, technology transfer, regulatory submission, and manufacturing preparation. This entire process has been made possible through collaboration among researchers, academia, industry, and global partners,” Shadiq said.. “Bio-RV 并不仅仅是引入一种新疫苗。这一成就的背后，是一段漫长的历程，涵盖了科学进步、工艺开发、临床前和临床研究、技术转让、监管申报以及生产准备。整个过程的实现得益于研究人员、学术界、产业界和全球合作伙伴之间的协作。”沙迪克说。According to Shadiq, Bio-RV’s neonatal dosing schedule provides an opportunity to establish protection against rotavirus from the earliest stage of life. 据Shadiq称，Bio-RV的新生儿剂量方案提供了从生命最早阶段建立对轮状病毒防护的机会。“What we aim to deliver is protection for Indonesian children as early as possible, while ensuring that Indonesia has the capacity to independently safeguard the continuity of vaccine supply. This forms part of Bio Farma’s contribution to strengthening national health resilience and sovereignty,” he added.. “我们的目标是在尽可能早的阶段为印尼儿童提供保护，同时确保印尼具备独立保障疫苗供应连续性的能力。这是生物法尔马公司为加强国家卫生韧性和主权所作贡献的一部分。”他补充道。Bio-RV originated from the RV3-BB vaccine candidate, based on a neonatal rotavirus strain developed by MCRI. The collaboration then progressed through clinical research and further development to prepare for Bio-RV production in Indonesia. Bio-RV 源于 RV3-BB 疫苗候选株，该候选株基于默多克儿童研究所（MCRI）开发的一种新生儿轮状病毒株。随后，双方通过临床研究和进一步开发推进合作，为在印度尼西亚生产 Bio-RV 做好准备。Human rotavirus was first identified in 1973 by MCRI Professor Ruth Bishop and Professor Ian Holmes from the University of Melbourne. Soon after, MCRI’s Professors Bishop and Barnes established a collaboration with UGM’s Professor Yati Soenarto, who was the first to confirm that rotavirus was the most common cause of diarrheal death and hospitalization in children in Indonesia. 人类轮状病毒于1973年由默多克儿童研究所（MCRI）的露丝·毕晓普教授和墨尔本大学的伊恩·霍尔姆斯教授首次发现。不久之后，MCRI的毕晓普教授和巴恩斯教授与印度尼西亚加查马达大学（UGM）的亚蒂·苏纳托教授建立了合作关系。亚蒂·苏纳托教授率先证实，轮状病毒是印度尼西亚儿童腹泻死亡和住院的最常见原因。In 1982, Professor Bishop identified RV3, an unusual rotavirus strain that infected newborn babies without causing disease and appeared to protect them from subsequent severe rotavirus diarrhea. . 1982年，Bishop教授鉴定出RV3，这是一种不寻常的轮状病毒株，可感染新生儿但不致病，并似乎能保护他们免受后续严重轮状病毒腹泻的影响。Building on this discovery, MCRI Professor Julie Bines led the development of RV3-BB as a live oral neonatal vaccine, taking it from a promising naturally occurring strain through clinical development in Australia, New Zealand and Indonesia. This work provided the foundation for Bio Farma’s Bio-RV vaccine. 在此发现的基础上，默多克儿童研究所（MCRI）的朱莉·拜恩斯教授领导了RV3-BB作为口服活体新生儿疫苗的研发工作，推动该疫苗从一种具有前景的自然毒株逐步完成在澳大利亚、新西兰和印度尼西亚的临床开发。这项工作为印尼生物法玛公司（Bio Farma）的Bio-RV疫苗奠定了基础。The close 50-year collaboration between the teams at UGM and. UGM 团队之间长达 50 年的紧密合作。MCRI has been pivotal to the clinical development of MCRI’s original RV3-BB vaccine and Bio Farma’s Bio-RV. The MCRI RV3-BB vaccine development was made possible through grants from the Gates Foundation and the Australian National Health and Medical Research Council. MCRI also acknowledges the Australian Government's enduring support for global health through the Department of Foreign Affairs and Trade.. 默多克儿童研究所（MCRI）在MCRI原创的RV3-BB疫苗以及印尼生物法玛公司（Bio Farma）的Bio-RV疫苗的临床开发中发挥了关键作用。MCRI RV3-BB疫苗的开发得益于盖茨基金会和澳大利亚国家健康与医学研究委员会提供的资助。MCRI还感谢澳大利亚政府通过外交贸易部对全球卫生事业提供的持续支持。Several partners have also supported the collaboration between Bio Farma and MCRI, including Universitas Gadjah Mada (UGM), Universitas Airlangga through the Airlangga Integrated Research Clinic (AIRC), and PATH at various stages of development. 多个合作伙伴也支持了Bio Farma与MCRI之间的合作，包括加查马达大学（UGM）、通过艾尔朗加综合研究诊所（AIRC）参与的艾尔朗加大学，以及PATH，在发展的各个阶段提供了支持。This collaboration has not only delivered a new vaccine but also strengthened Bio Farma’s capabilities to build Indonesia’s vaccine innovation ecosystem through cooperation among global research institutions, national academic institutions, and industry. Developing domestic capabilities across the Bio-RV development and manufacturing processes is expected to strengthen vaccine availability, reduce reliance on imported products, and support the sustainability of Indonesia’s National Immunization Program.. 此次合作不仅带来了一款新型疫苗，还通过全球研究机构、国家学术机构与产业界之间的协作，增强了印尼生物法玛公司（Bio Farma）构建印尼疫苗创新生态系统的能力。预计在本土建立涵盖Bio-RV研发和生产全流程的能力，将有助于提升疫苗供应稳定性，减少对进口产品的依赖，并支持印尼国家免疫计划的可持续发展。As part of the Danantara Indonesia ecosystem, Bio Farma remains committed to transforming national strategic assets and capabilities into tangible benefits for society while upholding good corporate governance, professionalism, and integrity. The development of Bio-RV represents a concrete contribution to improving quality of life through health innovation while strengthening Indonesia’s capabilities and competitiveness in the vaccine and life sciences industries.. 作为印尼Danantara生态系统的一部分，Bio Farma始终致力于将国家战略性资产和能力转化为社会的切实福祉，同时坚守良好的公司治理、专业精神和诚信原则。Bio-RV的研发是通过健康创新改善生活质量的实质性贡献，同时也增强了印尼在疫苗和生命科学产业的能力与竞争力。This initiative aligns with Danantara’s purpose, “Transforming National Assets into Prosperity with Integrity,” particularly through efforts to improve quality of life and build a stronger Indonesia supported by robust national healthcare industry capabilities. 这一倡议与达纳特拉的宗旨“以诚信将国家资产转化为繁荣”相契合，特别是通过改善生活质量，并依托强大的国家医疗健康产业能力，建设一个更强大的印度尼西亚。This achievement also reflects Bio Farma’s spirit of “Advancing Hope, Shaping the Future,” by turning hope into reality through health protection, science, innovation, and collaboration, while helping shape the future of healthcare in Indonesia and around the world. 这一成就也体现了印尼生物制药公司（Bio Farma）“推进希望，塑造未来”的精神，通过健康保护、科学、创新和合作将希望变为现实，同时助力塑造印度尼西亚乃至全球医疗保健的未来。Reporter: PR Wire 记者：PR WireEditor: PR Wire 编辑：PR WireCopyright © ANTARA 2026 版权所有 © ANTARA 2026

2024-03-15

·Science Daily

Common viruses trigger most cases of intussusception in children

Viral infections trigger more cases of intussusception, the common cause of bowel blockages in young children, than previously thought, according to a new study. Viral infections trigger more cases of intussusception, the common cause of bowel blockages in young children, than previously thought, according to a new study. The research, led by Murdoch Children's Research Institute (MCRI) and published in Clinical Infectious Diseases, found during the COVID-19 lockdowns hospital admissions for intussusception, a medical emergency involving obstruction of the intestine, among young children significantly decreased. For the study, 12 years of data was analysed across Victoria, NSW and Queensland. A total of 5,589 intussusception cases were recorded between January, 2010 and April, 2022. Of those, 3,179 were children under the age of two. During the lockdown periods, Victoria and NSW experienced a decline in hospital admissions for intussusception among children under two by 62.7 per cent and 40.1 per cent, respectively. The rate of intussusception cases has now returned to normal levels. MCRI and Monash University researcher Dr Ben Townley said the magnitude of the decline supported that common respiratory diseases such as colds, the flu and respiratory syncytial virus (RSV), were behind a significant proportion of intussusception cases. "Reductions in intussusception hospital admissions were seen in all age groups, however most occurred in children less than two years of age," he said. "Intussusception is the leading cause of acute bowel obstruction in infants and young children and without prompt diagnosis and management, can be fatal. "Countries with prolonged COVID-19 lockdowns and suppression strategies saw reductions in common respiratory viruses, which influenced the drop in intussusception admissions." Victoria experienced the greatest lockdown duration, with Melbourne having six lockdown periods, for a total of 263 days. Greater Sydney had 159 days and Brisbane had 18 days in lockdown. MCRI Professor Jim Buttery said the decrease in intussusception cases was greater than expected given previous research into the causes of the condition. "Our analysis found commons viruses play a larger role than previously recognised in triggering intussusception," he said. Infectious triggers were thought to comprise only a minority, about 30 per cent, of cases." Professor Buttery said the findings raised the possibility that emerging vaccines like the new RSV vaccines may help prevent intussusception. "When a new vaccine against common childhood respiratory viruses is introduced, we may find there are some unexpected benefits, like protecting more children from intussusception," he said. We last saw this in 2007, when introducing the rotavirus vaccine against gastroenteritis, also reduced febrile convulsions in young children." Researchers fromSydney Children's Hospital Network, University of Melbourne and Queensland Health also contributed to the findings.

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100 项与 Rotavirus vaccine (Bio-Farma/Murdoch-Childrens-Research-Institute) 相关的药物交易

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适应症	国家/地区	公司	日期
轮状病毒感染	印尼	PT Bio Farma	2026-09-03

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT03483116 (CTgov)	临床2期	轮状病毒感染	711	Placebo+RV3-BB (High Dose RV3-BB Neonatal Schedule)	製鹽遞醖壓夢製遞艱遞 = 糧鹹鹹願構鑰壓餘願網襯鏇積齋醖膚繭鹹鏇積 (淵簾繭範觸製壓衊獵觸, 襯淵觸憲餘窪獵獵餘夢 ~ 獵鑰糧淵顧製糧鏇鏇願) 更多	-	2023-07-10
				Placebo+RV3-BB (Mid Dose RV3-BB Neonatal Schedule)	製鹽遞醖壓夢製遞艱遞 = 襯獵鏇窪壓艱醖艱蓋壓襯鏇積齋醖膚繭鹹鏇積 (淵簾繭範觸製壓衊獵觸, 廠築膚鑰構繭蓋齋鹽簾 ~ 襯鏇範壓齋願獵鑰製鬱) 更多
NCT03483116 (Pubmed \| Lancet Infect Dis)	临床2期	轮状病毒引起的病毒性胃肠炎	711	Neonatal schedule high-titre RV3-BB vaccine	衊壓艱觸遞繭繭鹽願網(願繭餘獵膚蓋蓋範築願) = 願選製廠選網窪壓築餘襯願窪醖醖襯淵糧構遞 (遞繭襯襯簾製膚構衊鹽 ) 更多	积极	2022-01-20
				Neonatal schedule mid-titre RV3-BB vaccine	衊壓艱觸遞繭繭鹽願網(願繭餘獵膚蓋蓋範築願) = 願觸鹹齋鹹願築獵蓋鏇襯願窪醖醖襯淵糧構遞 (遞繭襯襯簾製膚構衊鹽 ) 更多
ACTRN12612001282875 (Pubmed \| N Engl J Med)	临床2期	轮状病毒感染	1,513	Human Neonatal Rotavirus Vaccine (RV3-BB)RV3-BBNeonatal Rotavirus Vaccine (RV3-BB) (RV3-BB neonatal schedule)	淵淵淵憲蓋製網積鬱遞(繭艱願餘壓範艱構構鹹) = The incidence of adverse events was similar across the groups 築襯廠積觸簾壓鏇顧鑰 (齋遞獵夢襯糧範選遞夢 )	积极	2018-02-22
				Human Neonatal Rotavirus Vaccine (RV3-BB)RV3-BBNeonatal Rotavirus Vaccine (RV3-BB) (RV3-BB infant schedule)