ACTRN12617001253392招募中未知
Protective Vaccine Responses in Infants after Maternal Pertussis Vaccination
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 入组人数
- 400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 6 Weeks 至 45 Years（—）
- 性别
- All
入选标准
- •Maternal Inclusion Criteria
- •Maternal participants must meet all of the following to be eligible to participate in the study:
- •1.Has provided written informed consent and is willing and able to comply with the scheduled visits and study procedures.
- •2.Generally well or any medical conditions are stable and well-controlled.
- •3.Aged 18 to less than or equal to 45 years.
- •4.English speaking with a good understanding of the English language.
- •5.Has received:
- •i)no adult dTap vaccination during their most recent pregnancy OR
- •ii)first adult dTap booster vaccination during their most recent pregnancy and at least 4 weeks prior to delivery OR
- •iii)second or subsequent adult dTap vaccination during their most recent pregnancy and at least 4 weeks prior to delivery.
- •Note: women who have received a dTap vaccination during the last 10 years, but not during their most recent pregnancy are eligible to participate as per inclusion criteria 5 i).
- •6.Their newborn infant is eligible to participate in the study (ie meets all of the infant inclusion criteria and none of the exclusion criteria).
- •7.Available for the entire study period.
- •Infant Inclusion Criteria
- •Infant participants must meet all of the following criteria to be eligible to participate in the study:
- •1. The infant’s parent has given written informed consent and is willing and able to comply with the scheduled visits and study procedures.
- •2. Is a healthy male or female infant born at term (equal to or greater than 37 weeks gestation)
- •3. Is available for the entire study period.
- •4. The infant’s mother is eligible to participate in the study (ie meets all of the maternal inclusion criteria and none of the exclusion criteria).
排除标准
- •Infant participants presenting with any of the following will not be eligible to participate in the study:
- •1.Already received their 6 week vaccinations (as recommended by the national immunisation schedule) prior to study visit 1.
- •2.Has received or plans to receive a Meningococcal ACWY conjugate vaccine prior to completing study visit 4 (28-42 days post-visit 3).
- •3.Has a diagnosed or suspected major congenital anomaly, genetic disorders or serious chronic illness.
- •4.Has a confirmed or suspected immunosuppressive or immunodeficient condition.
- •5.Has received immunoglobulins or any blood products since birth or planned administration during the study period.
- •6.Chronic administration of immunosuppressants since birth, including high-dose oral or parenteral corticosteroid therapy > 2mg/kg per day prednisolone for more than 2 weeks. Inhaled and topical corticosteroids are permitted.
- •7.Any contraindications to vaccination as listed in the current edition of the NHMRC Australian Immunisation Handbook.
- •8.Parent/legal guardian does not agree for their infant to be vaccinated as per the current national immunisation schedule, with the only exception being receipt of a third dose of pneumococcal vaccine at 6 months of age and a booster dose at 18 months of age (instead of 12 months of age) or planned administration of additional vaccinations (e.g. influenza, meningococcal B) within 2 weeks of the routine vaccinations administered during the study
- •Note: an infant is eligible to participate if they have not received a birth dose of Hepatitis B vaccine.
- •9.Current or planned participation in an investigational study (participation in observational studies is permitted) during the study period.
- •10.Has received any investigational or non-registered drugs, vaccines or devices since birth or planned during the study period.
- •11.Any other significant acute or chronic medical condition that in the opinion of the investigator may interfere with the interpretation of study results or place the participant at increased risk if they participate in the study.
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