ACTRN12617000065392招募中4 期
A double-blind, randomised, controlled trial to compare allergic outcomes in children following vaccination with acellular pertussis antigen given at 2 months of age versus whole cell pertussis in the infant vaccine schedule
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 3,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 6 Weeks 至 11 Weeks（—）
- 性别
- All
入选标准
- •An eligible infant must fulfill all of the following:
- •* Healthy male or female infant aged 6 to 11 weeks and 6 days old
- •* Born on or after 32 weeks
- •* Parent or guardian understands the information provided and is willing and able to give informed consent for participation in the trial
- •* Infant known to be free of significant medical problems as determined by a medical history and clinical examination by a medically qualified investigator
- •* Parent has access to a telephone
- •*Parent or guardian who is able and willing to comply with the requirements of the protocol in the opinion of an investigator
- •*Willing to allow his or her general practitioner and/or paediatrician and/or immunisation provider and/or other parties involved in the treatment of their child , to be notified of participation in the trial
- •*Willing to allow the study team to obtain information from the infant’s doctor, other health care professionals, hospitals or laboratories concerning the infant’s health from enrolment until 1 month after the 18-month vaccinations.
- •* Be available for the entire study period
排除标准
- •The participant may not enter the trial if ANY of the following apply:
- •* History of pre-existing parent-reported clinician diagnosed IgE-mediated food allergy
- •* History of pertussis infection
- •* Receipt of any prior vaccine, except for a single birth dose of hepatitis B vaccine within the first 7 days of life.
- •* Contra-indication to any routine infant immunisation: History of allergy, including anaphylaxis, to any vaccine or vaccine component
- •* Contra-indication to paracetamol
- •* Receipt of investigational vaccines/drugs, other than the vaccines used in the study, since birth or their planned use during the study period, until the final study visit (i.e. at approximately 19 months of age).
- •* Receipt, or planned receipt, of any non-routine vaccines within 14 days after the first dose of pertussis containing vaccine
- •* Receipt of more than 2 weeks of immunosuppressants or immune modifying drugs, (e.g. prednisolone >0.5mg/kg/day)
- •* Serious chronic illness including severe congenital anomalies affecting heart, brain and/or lungs.
- •* History of any neurologic disorders or seizures
- •* Administration of immunoglobulins and/or any blood products since birth or planned administration during the study period
- •* Planned travel to any country that remains at risk of a poliomyelitis outbreak at any time before the final phone/electronic contact (i.e. at approximately 19 months of age.)
- •* Parents who plans to move out of the geographical area where the study would be conducted
- •* Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial.
研究者
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