Background: Strains of 2 distinct influenza B lineages (Victoria and Yamagata) have cocirculated in the United States for over a decade, but trivalent influenza vaccines (TIVs) contain only 1 B-lineage strain. Each season, some or most influenza B disease is caused by the B lineage not represented in that season's TIV. Quadrivalent influenza vaccines (QIVs) containing a strain from each B lineage should resolve this problem.
Methods: This was a Phase III, randomized, multicenter trial in the United States among children 6 months to <9 years of age to evaluate the safety and immunogenicity of inactivated QIV compared with inactivated control TIVs containing opposite B-lineage strains. Participants were randomized at a ratio of approximately 4:1:1 to receive QIV, TIV containing a Victoria-lineage B strain or TIV containing a Yamagata-lineage B strain. Sera were collected pre- and 28-days post-final vaccination and safety was assessed for 6 months after the last injection.
Results: A total of 4363 participants were enrolled. QIV induced noninferior antibody responses to all A strains and corresponding B strains compared with the control TIVs and superior antibody responses to the noncorresponding B strain in each TIV. Rates of solicited reactions and unsolicited and serious adverse events were similar in all groups.
Conclusions: This study demonstrated that QIV is safe and immunogenic among children 6 months to <9 years of age. These findings, along with data from 2 other studies of this QIV in adults, suggest that QIV should offer protection against both B lineages with a safety profile similar to TIV across all ages.
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http://dx.doi.org/10.1097/INF.0000000000000254 | DOI Listing |
JAMA Netw Open
January 2025
Transformative Health Systems Research to Improve Veteran Equity and Independence Center of Innovation, Veterans Affairs Providence Health Care System, Providence, Rhode Island.
Clin Microbiol Infect
December 2024
Scientific Committee of the Foundation 'Allineare Sanità e Salute' Milan, Via Ricordi, 4 - 20131 Milano - Italy. Electronic address:
Sci Rep
December 2024
State Key Laboratory for Diagnosis, Treatment of Infectious Diseases, National Clinical Research Center for Infectious Diseases, Collaborative Innovation Center for Diagnosis and Treatment of Infectious Diseases, The First Affiliated Hospital, School of Medicine, Zhejiang University, Hangzhou, 310003, China.
Influenza virus infections are a serious danger to people's health worldwide as they are responsible for seasonal flu outbreaks. There is an urgent need to improve the effectiveness and durability longevity of the immune response to influenza vaccines. We synthesized the CpG HP021 and examined the impact of it on the immune response to an influenza vaccine.
View Article and Find Full Text PDFHum Vaccin Immunother
December 2025
Hangzhou Disease Prevention and Control Center, Hangzhou, P.R. China.
From 2020, influenza viruses circulation was largely affected by the global coronavirus disease (COVID-19) pandemic, notably leading to the extinction of the B/Yamagata lineage and raising questions about the relevance of the quadrivalent influenza vaccine, which includes this lineage. Evaluating vaccine effectiveness (VE) against influenza infections is important to inform future vaccine programs. A test-negative case-control study was conducted in five tertiary hospitals in Hangzhou, the capital city of Zhejiang province, China, enrolling medically-attended patients aged >6 months who presented with influenza-like illness (ILI) from October 1, 2023, to March 31, 2024.
View Article and Find Full Text PDFClin Epidemiol
December 2024
Data and Analytics, Finnish Institute for Health and Welfare (THL), Helsinki, Finland.
Purpose: We developed a hybrid safety surveillance approach for a large, pragmatic clinical trial of a high-dose quadrivalent influenza vaccine (QIV-HD), using both active and passive data collection methods. Here, we present the methods and results for the passive register-based surveillance of serious adverse events (SAEs), which replaced conventional SAE reporting during the trial.
Patients And Methods: The trial recruited over 33,000 older adults of whom 50% received the QIV-HD while the rest received a standard-dose vaccine (QIV-SD) as a control vaccine.
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