Enhanced Post-licensure Safety Surveillance Study of the Combined Tetanus, Diphtheria (Reduced Dose) and Recombinant Acellular Pertussis Vaccine (TdaP), Boostagen®, in Thailand
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10,727
- 试验地点
- 1
- 主要终点
- Incidence and percentage of AEFIs following vaccination with Boostagen®
研究概览
简要总结
This study is designed to monitor the safety of Boostagen® after it has been approved for use in Thailand. The study follows people who receive the vaccine in routine medical practice to identify and record any side effects.
Doctors, nurses, and other healthcare professionals from hospitals and clinics in central, eastern, southern, and northern Thailand take part in the study. They report any health problems that occur after vaccination using standard reporting forms.
The information collected helps researchers understand how safe the vaccine is when used in a large and diverse population under real-world conditions.
Primary objective: To describe the post-licensure safety profile of Boostagen® in Thailand.
Secondary objective: To identify any unexpected safety signals following vaccination with Boostagen®.
详细描述
HCPs eligible to participate were those who prescribed or administered Boostagen®. as a booster immunization in line with national guidelines. Recruitment was carried out in hospitals and clinics located in central, eastern, southern and northern Thailand. HCPs who agreed to participate were interviewed periodically regarding adverse events following immunization (AEFIs) with Boostagen®.
Data collection was performed using a standardized questionnaire administered monthly, either in person or by telephone. The questionnaire captured the number and type of AEFIs observed, along with other safety-related information.
HCPs used a modified WHO AEFI report form to document adverse events. In addition, a pregnancy safety outcome report form was developed to collect data on pregnancy outcomes among vaccinated pregnant women and their newborn. This structured approach enabled systematic monitoring's safety profile in real-world conditions and ensured early identification of any unexpected safety signals.
Statistical Analysis. No formal prespecified study hypothesis was established. Descriptive statistical methods were applied to summarize demographic and baseline characteristics of Boostagen® recipients, including children, adolescents, adults, and pregnant women. The incidence rates and proportions of AEFIs were calculated. For pregnant women vaccinated with Boostagen®, pregnancy outcomes, pregnancy-related complications, and neonatal outcomes were summarized. Continuous variables were described using means and standard deviations, while categorical variables were presented as frequencies and percentages. Ninety-five percent confidence intervals (95% CIs) were calculated where appropriate. All statistical analyses were performed using SPSS software, version 18.0 (SPSS Inc., Chicago, IL, USA).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •An HCP will be eligible for inclusion if ALL of the following criteria are met at the time of screening:
- •Has prescribed and/or administered Boostagen® to children, adolescents and adults in accordance with current national immunization guidelines.
- •Employed full-or part-time (> 8 hours/week) in a government or private hospital or medical clinic.
- •Available for follow-up by telephone call, email or site visit if there are missing information in the study questionnaire, to confirm the occurrence or clarify the nature of an adverse event following immunization with Boostagen®.
- •Willing and able to comply with the study procedures.
排除标准
- •Unwilling to take part in the study.
研究组 & 干预措施
Boostagen® recipients
Vaccinees consist of children, adolescents and adults including pregnant women in private and government hospitals and clinics located in the central, eastern, northern, and southern regions of Thailand.
结局指标
主要结局
Incidence and percentage of AEFIs following vaccination with Boostagen®
时间窗: From the date of vaccination up to 30 days post-vaccination.
Measure the frequency, categorize the types, assess the severity, and determine the causal relationship to vaccination for all AEFIs.
Incidence and percentage of pregnant women vaccinated with Boostagen® who had experienced complications during pregnancy
时间窗: From administration of Boostagen® during pregnancy until delivery
Incidence rate is defined as the number of maternal complications in 1000 vaccinees. Pregnancy complications include but are not limited to the following: pregnancy loss or stillbirth, preterm delivery (\< 37 weeks of gestation), premature rupture of membranes, pregnancy-induced hypertension, pre-eclampsia/eclampsia, intrauterine growth restriction (IUGR), obstetric hemorrhage, and gestational diabetes.
Incidence and percentage of healthy and not healthy infants born to mothers who received Boostagen® during pregnancy
时间窗: From maternal vaccination during pregnancy until birth of the infant
Incidence rate is defined as the number of healthy and not healthy infants in 1000 infants born to mothers who received Boostagen® during pregnancy. This outcome assesses the health status of infants born to mothers who received Boostagen® during pregnancy. Infants will be classified at birth as healthy or not healthy based on clinical assessment and review of delivery and neonatal records. A healthy infant is defined as a live-born infant without any congenital anomalies, neonatal complications, or conditions requiring significant medical intervention at birth. A not healthy infant is defined as a live-born infant with at least one reported adverse neonatal outcome, including but not limited to congenital anomalies, preterm birth, low birth weight, neonatal intensive care unit (NICU) admission, or other clinically significant medical conditions identified at or shortly after birth.
次要结局
- Incidence and percentage of unexpected serious adverse events (SAEs) following Boostagen vaccination.(From the date of vaccination up to 30 days post-vaccination for adults and up to delivery for pregnant women.)
- Incidence and percentage of rare adverse events following Boostagen® vaccination(From the date of vaccination up to 30 days post-vaccination for adults and up to delivery for pregnant women.)
- Incidence and percentage of new patterns of known adverse events(From the date of vaccination up to 30 days post-vaccination for adults and up to delivery for pregnant women.)