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Reactogenicity and safety of a liquid human rotavirus vaccine (RIX4414) in healthy adults, children and infants in China: randomized, double-blind, placebo-controlled Phase I studies.

Author: HanHtay Htay, HuangTeng, KarkadaNaveen, KongJi-Lian, LiRong-Cheng, LiYan-Ping, LiaoXueyan, LiuAixue, LuoDong, MoZhao-Jun, SongNing-Sheng, WangLao-Hong, ZhangHelen

Randomized Controlled TrialA clinical trial that randomly assigns participants to treatment and control groups to evaluate the effects of an intervention.
Clinical Trial, Phase IThe first stage of clinical trials in humans. Evaluates the safety, tolerability, and pharmacokinetics of a new drug/treatment.
Journal ArticleAn article published in an academic or professional journal that reports original research or scholarly analysis.
Research Support, Non-U.S. Gov'tResearch funding provided by government agencies outside the United States.

Overview

A liquid formulation of the human G1P[8] rotavirus (RV) vaccine (RIX4414) was found to be safe and well-tolerated in adults, children, and infants. In infants, the anti-RV IgA antibody seroconversion rate after two vaccine doses was 86.7%.
Paper Details　
Original Abstract of the Article :
We report the findings of three randomized, double-blind, placebo-controlled Phase I studies undertaken to support licensure of the liquid formulation of the human G1P[8] rotavirus (RV) vaccine (RIX4414; GlaxoSmithKline Biologicals SA) in China. Healthy adults aged 18-45 y (n=48) and children aged 2...See full text at original site
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引用元：
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC3906260/

データ提供：米国国立医学図書館（NLM）

The Safety and Reactogenicity of a Liquid Human Rotavirus Vaccine (RIX4414)

The field of vaccine research strives to develop safe and effective immunizations to protect against various diseases. This research focuses on the safety and reactogenicity profile of a liquid human rotavirus vaccine (RIX4414) in different age groups, including adults, children, and infants. The study utilized a randomized, double-blind, placebo-controlled design to assess the vaccine's safety and immunogenicity.

A Well-Tolerated Vaccine: Safety and Immunogenicity of RIX4414

The research demonstrated that RIX4414 was well-tolerated in all age groups studied. The reactogenicity profile, which refers to any adverse reactions or side effects, was comparable to that of the placebo. In infants, the vaccine achieved a high seroconversion rate, indicating the development of a protective immune response. This finding is particularly encouraging for infants, who are especially vulnerable to rotavirus infections.

Protecting the Young: Promising Implications for Rotavirus Prevention

The results of this study suggest that RIX4414 holds potential for preventing rotavirus infections in infants. Rotavirus is a common and often severe viral infection, particularly in young children. The development of a safe and effective vaccine could significantly reduce the burden of this disease worldwide.

Dr. Camel's Conclusion

My dear friends, this study is like a refreshing breeze blowing through the desert of vaccine research! It shows that we are making progress in developing safe and effective vaccines to protect our most vulnerable populations. Imagine the sands of the desert being replaced by a lush oasis of health and well-being, thanks to this promising new vaccine. With the development of vaccines like RIX4414, we are one step closer to building a healthier and brighter future for all.
Date :
  1. Date Completed 2014-05-06
  2. Date Revised 2021-10-21
Further Info :

Pubmed ID

23807360

DOI: Digital Object Identifier

PMC3906260

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Languages

English

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