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临床试验/EUCTR2009-015174-35-NO
EUCTR2009-015174-35-NO进行中（未招募）1 期

A phase II, randomised, open-label study to evaluate the safety and immunogenicity of the adjuvanted pandemic H1N1 influenza candidate vaccine following a 0-28 day or 0-4 month vaccination schedule in subjects aged 8 to 12 weeks. - FLU D-PAN H1N1-012

GlaxoSmithKline Biologicals0 个研究点开始时间: 2009年10月8日最近更新:
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适应症
相关药物

试验速览

阶段
1 期
状态
进行中（未招募）
研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • •-Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
  • •-Children, male or female, aged between 8 and 12 weeks at the time of first study vaccination.
  • •-Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • •-Healthy children, as established by medical history and clinical examination when entering the study.
  • •-Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
  • •-Born after a gestation period larger or equal to 36 weeks to less than or equal to 42 weeks.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range
  • •-Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
  • •-Children, male or female, aged between 8 and 12 weeks at the time of first study vaccination.
  • •-Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • •-Healthy children, as established by medical history and clinical examination when entering the study.
  • •-Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
  • •-Born after a gestation period larger or equal to 36 weeks to less than or equal to 42 weeks.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range
  • •-Subjects who the investigator believes that their parent(s)/Legally Acceptable Representative(s) can and will comply with the requirements of the protocol.
  • •-Children, male or female, aged between 8 and 12 weeks at the time of first study vaccination.
  • •-Written informed consent obtained from the parent(s)/LAR(s) of the subject.
  • •-Healthy children, as established by medical history and clinical examination when entering the study.
  • •-Parent/LAR with access to a consistent means of telephone contact, land line or mobile, but NOT a pay phone or other multiple-user device.
  • •-Born after a gestation period larger or equal to 36 weeks to less than or equal to 42 weeks.
  • •Are the trial subjects under 18? yes
  • •Number of subjects for this age range:
  • •F.1.2 Adults (18-64 years) no
  • •F.1.2.1 Number of subjects for this age range
  • •F.1.3 Elderly (>=65 years) no
  • •F.1.3.1 Number of subjects for this age range

排除标准

  • •-Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
  • •-Acute disease at the time of enrolment.
  • •-Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • •-History of any neurological disorders or seizures.
  • •-A family history of congenital or hereditary immunodeficiency.
  • •-Receipt of systemic glucocorticoids within one month of study enrolment, or any other cytotoxic or immunosuppressive drug since birth.
  • •-Administration of any vaccines within two weeks before study enrolment.
  • •-Administration of immunoglobulins and/or any blood products since birth or planned administration during the study.
  • •-Previous administration of any H1N1 vaccine, of any seasonal influenza vaccine.
  • •-Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations.
  • •-History of intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b disease.
  • •-Major congenital defects or serious chronic illness.
  • •-Child in care.
  • •-Any known or suspected allergy to any constituent of the influenza, DTPa-IPV/Hib and pneumococcal study vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza, DTPa-IPV/Hib and pneumococcal vaccine.
  • •-Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
  • •-Acute disease at the time of enrolment.
  • •-Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • •-History of any neurological disorders or seizures.
  • •-A family history of congenital or hereditary immunodeficiency.
  • •-Receipt of systemic glucocorticoids within one month of study enrolment, or any other cytotoxic or immunosuppressive drug since birth.
  • •-Administration of any vaccines within two weeks before study enrolment.
  • •-Administration of immunoglobulins and/or any blood products since birth or planned administration during the study.
  • •-Previous administration of any H1N1 vaccine, of any seasonal influenza vaccine.
  • •-Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations.
  • •-History of intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b disease.
  • •-Major congenital defects or serious chronic illness.
  • •-Child in care.
  • •-Any known or suspected allergy to any constituent of the influenza, DTPa-IPV/Hib and pneumococcal study vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza, DTPa-IPV/Hib and pneumococcal vaccine.
  • •-Use of any investigational or non-registered product other than the study vaccine within 30 days preceding the first dose of the study vaccine or planned use during the study period.
  • •-Acute disease at the time of enrolment.
  • •-Any confirmed or suspected immunosuppressive or immunodeficient condition based on medical history and physical examination.
  • •-History of any neurological disorders or seizures.
  • •-A family history of congenital or hereditary immunodeficiency.
  • •-Receipt of systemic glucocorticoids within one month of study enrolment, or any other cytotoxic or immunosuppressive drug since birth.
  • •-Administration of any vaccines within two weeks before study enrolment.
  • •-Administration of immunoglobulins and/or any blood products since birth or planned administration during the study.
  • •-Previous administration of any H1N1 vaccine, of any seasonal influenza vaccine.
  • •-Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b, and/or Streptococcus pneumoniae with the exception of vaccines where the first dose can be given within the first two weeks of life according to the national recommendations.
  • •-History of intercurrent diphtheria, tetanus, pertussis, poliomyelitis, Haemophilus influenzae type b disease.
  • •-Major congenital defects or serious chronic illness.
  • •-Child in care.
  • •-Any known or suspected allergy to any constituent of the influenza, DTPa-IPV/Hib and pneumococcal study vaccines; a history of anaphylactic-type reaction to consumption of eggs; or a history of severe adverse reaction to a previous influenza, DTPa-IPV/Hib and pneumococcal vaccine.

研究者

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