Immunogenicity and safety of a live attenuated varicella vaccine in children 1–12 years of age: A randomized, blinded, controlled, non-inferiority phase 3 clinical trial

Jiang, Feng; Zhang, Ruizhi; Guan, Qinghu; Mu, Qiuyue; He, Ping; Ye, Xingui; Wang, Wenjian; Quan, Jidong; Jiaqiang, LI; Liang, Luxiang; Zeng, Fengxiu; Tang, Ning; Xu, Fei; Wu, Peng; Yu, Xiaoli; Yu, Xiaoqing; Zheng, Longchao; Zhao, Yun; Cai, Mingyong; Li, Cheng; Zhong, Yang; Cao, Xiamin; Yu, Yu; Zhang, Xingyu; Zhang, Tao; Wang, Peiyong; Lei, Shiguang

doi:10.1016/j.cct.2021.106489

Cited by 3 publications

(2 citation statements)

References 13 publications

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“…Nolan et al [ 39 ]* Meningococcal conjugate vaccine • Less than 24.6% of all participants • HibMenC vaccine: 24% • HiB + MCC vaccine: 20% • No placebo group reported • Grade 3 HiB + MCC: about 5% • Headache was one of the most common solicited general symptom along with fatigue and gastrointestinal symptoms • No VAEs were considered to be related to vaccine, study procedures, or concomitant medication 38. Jiang et al [ 40 ]* Varicella vaccine 5 (0.84%) 2 (0.67%) Vaccine: • Grade one: 4 (0.67%) Headache • Grade 2: 1 (0.17%) • Grade 3: 0 (0%) Placebo: • Grade 1: 1 (0.34%) • Grade 2: 0 (0%) • Grade 3: 1 (0.34%) Headache in the vaccine group was greater than the placebo group 39. Asatryan et al [ 41 ] Combined diphtheria, tetanus, pertussis vaccine 24.9% CI [20.9–29.3) • No placebo group reported • Grade 3: 2.1% [1.0–3.9] • Headache related to the vaccine group: 18.9 CI [15.3–22.9] • Grade 3 headache was considered if headache prevented normal activity • Headache was one of two most common solicited VAEs • In participants 65 years and older, headache was unrelated to vaccine in 50% of cases 40.…”

Section: Methodsmentioning

confidence: 99%

Headache After Vaccination: An Update on Recent Clinical Trials and Real-World Reporting

Garces

Cocores

Goadsby

et al. 2022

Curr Pain Headache Rep

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Purpose of Review The aim of this review is to characterize headache as a vaccine adverse event (VAE) in clinical trials. Recent Findings Of the recent phase III vaccine RCTs (non-COVID-19), 53 studies reported on headache (13 infectious agents). The median rate (interquartile range) of headache was 15.6% ( IQR : 9.6–37.6%). Of these, 24.5% of the RCTs reported headache greater in the vaccine group compared to the placebo/control group. In the herpes zoster vaccination trials, headache was more common in all active groups: median rate 33.9% ( IQR : 29.7–40.5%) as compared to placebo: median rate 17.7% ( IQR : 15.4–23.8%). Influenza and HPV vaccination trials were the 2nd and 3rd most common to have headache as a VAE. Of the 6 widely distributed COVID-19 vaccinations, median rate of post-vaccination headache was 39% ( IQR : 28–50%). Summary Headache is a common VAE in vaccine trials. Standardized grading methods, predictors of persistence, and treatment regimens are warranted.

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Section: Methodsmentioning

confidence: 99%

Headache After Vaccination: An Update on Recent Clinical Trials and Real-World Reporting

Garces

Cocores

Goadsby

et al. 2022

Curr Pain Headache Rep

View full text Add to dashboard Cite

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“…Attenuated vaccines are widely used against various infectious diseases such as smallpox [92,93], Varicella [94,95], Japanese encephalitis [96,97], and yellow fever [98,99]. This type of vaccine is highly immunogenic [100,101], safe based on its history of use [102,103]. Live attenuated vaccine viruses are used for the delivery of antigenic substances and are also widely researched for the treatment of tumors and other diseases [104][105][106][107].…”

Section: Strategy Three: Live Attenuated Viral Vaccine Delivered Sars...mentioning

confidence: 99%

Advances in Next-Generation Coronavirus Vaccines in Response to Future Virus Evolution

Wei

Han

et al. 2022

Vaccines

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Coronavirus disease (COVID-19), caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has spread to more than 230 countries and territories worldwide since its outbreak in late 2019. In less than three years, infection by SARS-CoV-2 has resulted in over 600 million cases of COVID-19 and over 6.4 million deaths. Vaccines have been developed with unimaginable speed, and 11 have already been approved by the World Health Organization and given Emergency Use Listing. The administration of several first-generation SARS-CoV-2 vaccines has successfully decelerated the spread of COVID-19 but not stopped it completely. In the ongoing fight against viruses, genetic mutations frequently occur in the viral genome, resulting in a decrease in vaccine-induced antibody neutralization and widespread breakthrough infection. Facing the evolution and uncertainty of SARS-CoV-2 in the future, and the possibility of the spillover of other coronaviruses to humans, the need for vaccines with a broad spectrum of antiviral variants against multiple coronaviruses is recognized. It is imperative to develop a universal coronavirus or pan-coronavirus vaccine or drug to combat the ongoing COVID-19 pandemic as well as to prevent the next coronavirus pandemic. In this review, in addition to summarizing the protective effect of approved vaccines, we systematically summarize current work on the development of vaccines aimed at suppressing multiple SARS-CoV-2 variants of concern as well as multiple coronaviruses.

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Immunogenicity and safety of a live attenuated varicella vaccine co-administered with inactive hepatitis A vaccine: A phase 4, single-center, randomized, controlled trial

Sun

et al. 2023

Human Vaccines & Immunotherapeutics

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Immunogenicity and safety of a live attenuated varicella vaccine in children 1–12 years of age: A randomized, blinded, controlled, non-inferiority phase 3 clinical trial

Cited by 3 publications

References 13 publications

Headache After Vaccination: An Update on Recent Clinical Trials and Real-World Reporting

Headache After Vaccination: An Update on Recent Clinical Trials and Real-World Reporting

Advances in Next-Generation Coronavirus Vaccines in Response to Future Virus Evolution

Immunogenicity and safety of a live attenuated varicella vaccine co-administered with inactive hepatitis A vaccine: A phase 4, single-center, randomized, controlled trial

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