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
概览
- 阶段
- 4 期
- 干预措施
- 未指定
- 疾病 / 适应症
- 未指定
- 发起方
- niversity of Sydney
- 入组人数
- 3000
- 状态
- 招募中
- 最后更新
- 2年前
概览
简要总结
暂无简介。
研究者
入排标准
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.
结局指标
主要结局
未指定
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