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The study on pregnant women receiving quadrivalent influenza virus subunit vaccine has successfully completed key enrollment
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- Time of issue:2026-02-10
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(Summary description)Recently, the vaccination of pregnant women with quadrivalent influenza virus subunit vaccine (HRK-X®) was officially launched on March 1, 2025, jointly carried out by the First Affiliated Hospital of Chongqing Medical University and the Disease Prevention and Control Center of Yuzhong District, Chongqing ®） The safety and immune efficacy research of this groundbreaking clinical study has made significant progress - all participants have successfully completed the enrollment, marking the beginning of a new stage.
The study on pregnant women receiving quadrivalent influenza virus subunit vaccine has successfully completed key enrollment
(Summary description)Recently, the vaccination of pregnant women with quadrivalent influenza virus subunit vaccine (HRK-X®) was officially launched on March 1, 2025, jointly carried out by the First Affiliated Hospital of Chongqing Medical University and the Disease Prevention and Control Center of Yuzhong District, Chongqing ®） The safety and immune efficacy research of this groundbreaking clinical study has made significant progress - all participants have successfully completed the enrollment, marking the beginning of a new stage.
- Categories:Company news
- Author:
- Origin:
- Time of issue:2026-02-10 09:09
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Recently, the vaccination of pregnant women with quadrivalent influenza virus subunit vaccine (HRK-X®) was officially launched on March 1, 2025, jointly carried out by the First Affiliated Hospital of Chongqing Medical University and the Disease Prevention and Control Center of Yuzhong District, Chongqing ®） The safety and immune efficacy research of this groundbreaking clinical study has made significant progress - all participants have successfully completed the enrollment, marking the beginning of a new stage.
The successful completion of this enrollment work fills the gap in clinical data of influenza vaccines for pregnant women in China, and provides solid scientific evidence from the Chinese population for the international consensus that "influenza vaccination during pregnancy is safe".
Influenza, as a highly contagious acute respiratory disease, causes seasonal outbreaks every year and poses a persistent threat to special populations. Pregnant women may experience physiological changes in their cardiovascular and respiratory systems during pregnancy, resulting in a special immune status. They not only have a higher risk of infection and more severe symptoms, but may also progress to severe illness or even death. Meanwhile, high fever caused by influenza can also increase the risk of adverse pregnancy outcomes such as premature birth.
Although both the World Health Organization and the Chinese Center for Disease Control and Prevention have explicitly listed pregnant women as a priority group for influenza vaccination, there has been a lack of clinical data on vaccines for this group in China for a long time. Some vaccine instructions still list pregnant women as contraindicated, resulting in a significantly lower vaccination rate for pregnant women in China compared to international levels. In addition, infants under 6 months of age cannot receive the influenza vaccine, making maternal antibodies the only key immune barrier to protect newborns. These practical factors collectively constitute a severe challenge in the current prevention of maternal and infant influenza.
To this end, the First Affiliated Hospital of Chongqing Medical University and the Disease Prevention and Control Center of Yuzhong District, Chongqing have conducted significant clinical studies. This clinical study strictly follows a randomized, double-blind, and scientifically standardized research design, systematically evaluating the safety, immunogenicity, and maternal antibody protective effect of the quadrivalent influenza virus subunit vaccine in pregnant women. The aim of this study is to provide clear clinical evidence for pregnant women to receive influenza vaccines, increase the number of suitable populations, and solve the practical dilemma of "wanting to receive the vaccine but having no basis, and medical staff being afraid to recommend it". It not only helps pregnant women obtain direct protection during pregnancy, but also establishes a key immune defense line for fetuses and infants aged 0-6 months through maternal antibodies, thus safeguarding maternal and infant health and safety from the source.
Relevant information
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How to choose a reliable influenza vaccine during the flu season? An evidence-based guide for subunit vaccines for all age groupsInfluenza (commonly referred to as the flu) is an acute respiratory infectious disease caused by the influenza virus. Unlike the common cold, influenza is highly contagious and is characterized primarily by systemic symptoms. Elderly individuals, children under the age of 5, patients with chronic diseases, pregnant women, and individuals with compromised immune systems are all considered high-risk populations for severe influenza [1]. A study based on national influenza surveillance and cause-of-death surveillance data revealed that, on average, there are 88,000 excess deaths related to influenza-associated respiratory diseases annually across China [2]. The total economic burden on outpatient patients with influenza ranges from RMB 801 to RMB 1,320, while the total economic burden on hospitalized influenza patients ranges from RMB 9,832 to RMB 23,833 [1]. In the face of the significant challenge posed by influenza, influenza vaccination is currently recognized worldwide as the most cost-effective and effective means of preventing influenza [1]. - The leap in influenza vaccine technology: from split-virus vaccines to whole-population subunit vaccines – what are the key advancements in the third-generation vaccines? 08-19
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