Immunogenicity of a Single Dose of GSK Biologicals' Diphtheria, Tetanus and Acellular Pertussis (dTpa) Booster Vaccine (Boostrix™ [263855]) in Infants Prior to Primary Pertussis Vaccination, When Administered to Pregnant Women as Per Routine Practice in Bogota, Colombia
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Number of seropositive subjects for anti-pertussis toxin (PT), anti-filamentous haemagglutinin (FHA) and anti-pertactin (PRN).
研究概览
简要总结
The purpose of the study is to support the recommendation of vaccination of all pregnant women in Colombia with Diptheria, tetanus and pertussis (dTpa) by studying the transfer of pertussis specific IgG antibodies from mother to the child.
详细描述
This study will assess the immunogenicity in infants (at birth and just prior to primary pertussis vaccination [i.e. diphtheria, tetanus and pertussis [DTP] vaccination] administered at 8 weeks of age), of a single Boostrix booster dose administered to their mothers during the second or third trimester as per routine practice in Bogota, Colombia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- — 至 8 Weeks（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Criteria applicable at screening (before the birth of the infant):
- •Male or female infants whose mothers have received Boostrix during their current pregnancy, as per routine practice.
- •Infant whose parents, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •Written informed consent obtained from both parents of the infant.
- •Criteria applicable at enrolment (after the birth of the infant):
- •Confirmation of written informed consent obtained from both parents of the infant at the time of screening.
- •Infant whose parents, in the opinion of the investigator, can and will comply with the requirements of the protocol.
排除标准
- •Criteria applicable at screening (before the birth of the infant):
- •Infants whose parents are below the legal consenting age of the country.
- •Infant's whose mother has multiple pregnancies.
- •Infant's whose mother has any confirmed or suspected immunosuppressive or immunodeficient condition (including positive infection with human immunodeficiency virus [HIV]), based on medical history, physical examination or positive test result.
- •Infant's whose mother is concurrently participating in another clinical study, at any time during the study period, in which the infant's mother has been or will be exposed to an investigational or a non-investigational vaccine/product.
- •Criteria applicable at enrolment (after the birth of the infant):
- •Child in care.
- •In case of multiple births.
- •Infants with any confirmed or suspected immunosuppressive or immunodeficient condition , based on medical history, physical examination or positive test result.
- •Infants who are concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational vaccine/product.
结局指标
主要结局
Number of seropositive subjects for anti-pertussis toxin (PT), anti-filamentous haemagglutinin (FHA) and anti-pertactin (PRN).
时间窗: For cord blood sample - Visit 1 (Day 0). For blood samples collected from infants prior to their first routine primary pertussis vaccination - Visit 2 (at approximately 4-8 weeks of age of subjects).
Seropositivity status was defined as anti-PT, anti-FHA and anti-PRN antibody concentrations ≥ 5 EL.U/mL.
次要结局
- Number of seropositive subjects for anti-PT, anti-FHA and anti-PRN.(At birth (Day 0) and before primary vaccination (between Day 28 and Day 56).)
- Anti-PT, anti-FHA and anti-PRN antibody concentrations.(At birth (Day 0) and before primary vaccination (between Day 28 and Day 56).)