Immune Response to Pertussis After Vaccination With a Tdap-IPV Booster Vaccine in Children in the Republic of South Africa: Effect of Homologous and Heterologous Pertussis Vaccination Priming Background

Sanofi Pasteur, a Sanofi Company3 个研究点分布在 1 个国家目标入组 273 人开始时间: 2021年1月27日最近更新: 2025年9月12日

适应症

干预措施

试验速览

阶段: 4 期
状态: 已完成
发起方: Sanofi Pasteur, a Sanofi Company
入组人数: 273
试验地点: 3
主要终点: GMCs of anti-diphtheria IgG

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Primary Objectives :

To describe the long-term humoral immune responses to pertussis, diphtheria, and tetanus after homologous and heterologous pertussis vaccine priming regimens
To determine the effects of the priming regimen on humoral responses to booster vaccination with Tdap-IPV vaccine
To describe the long-term cell-mediated immune responses to pertussis after homologous and heterologous pertussis vaccine priming regimens
To determine the effects of the priming regimen on cell-mediated immune response to booster vaccination with Tdap-IPV vaccine

Secondary Objective:

To describe the safety profile of Tdap-IPV vaccine in each group

详细描述

Study duration per participant will be approximately 30 days including: 1 day of screening and vaccination, a phone call and a safety follow-up/end of study visit, at Day 8 and Day 30 after vaccine administration, respectively.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

年龄范围: 8 Years 至 14 Years（Child）
性别: All
接受健康志愿者: 是

入选标准

•Born in 2007 to 2011 in the RSA
•Received primary pertussis vaccination and the toddler booster in the RSA
•Assent form has been signed and dated by the participant, and informed consent form (ICF) has been signed and dated by the parent(s) or another legal guardian and by an independent witness, if required by local regulations
•Participants and parent/legal guardian are able to attend all scheduled visits and to comply with all trial procedures
•Valid clinical record of primary vaccination with DTaP/DTwP vaccines immunization history from 2007 through 2011, either by hand-held (Road-to-Health Card) or immunization clinical records
•For Groups 6 and 7: children infected with perinatally acquired HIV infection currently under care who received either an all wP or all aP priming regimen
•For Groups 6 and 7: be on highly active antiretroviral therapy (HAART) therapy and have known CD4 cell counts > 200 cells/µL

排除标准

•Participation in the 4 weeks preceding the vaccination or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
•Receipt of any vaccine in the 4 weeks preceding the trial vaccination or planned receipt of any vaccine in the 4 weeks following the trial vaccination except for influenza
•Receipt of additional pertussis vaccination doses inconsistent with pertussis vaccination schedule in the RSA
•Previous confirmed diagnosis of pertussis disease
•Receipt of immune globulins, blood or blood-derived products in the past 3 months
•Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
•For Groups 1 to 5: known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy, within the preceding 6 months; or long-term systemic corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks within the past 3 months)
•Known thrombocytopenia, as reported by the parent/ legal guardian or suspected thrombocytopenia contraindicating intramuscular vaccination in the Investigator's opinion
•Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating intramuscular vaccination
•Participants with progressive neurological disorder, uncontrolled epilepsy, or progressive encephalopathy except if a treatment regimen has been established and the condition has stabilized
•Encephalopathy within 7 days of a previous dose of pertussis-containing vaccine
•Had contraindication to receipt of Adacel Quadra vaccine at the time of vaccination as defined in the Adacel Quadra vaccine Republic of South Africa (RSA) label
•Moderate or severe acute illness/infection (according to Investigator judgment) on the day of vaccination or febrile illness (temperature ≥ 38.0°C [≥ 100.4°F]). A prospective participants should not be included in the study until the condition has resolved or the febrile event has subsided (temporary contraindication)
•Receipt of oral or injectable antibiotic therapy within 72 hours prior to the first blood draw Note: Potential participants receiving standard HIV treatments such as antiretrovirals and/or antibiotic prophylaxis can be enrolled in the study. Their routine medications should be documented in the CRB.
•Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study

研究组 & 干预措施

Group 1: Adacel Quadra vaccine

Experimental

Adacel Quadra single injection at Day 0 in participants who received 4 doses of whole-cell pertussis (wP) vaccine during the first 2 years of life