EUCTR2011-002946-11-Outside-EU/EEA进行中（未招募）不适用
A phase IIIb, open label, randomized, multicenter study of the im-munogenicity and safety of a booster dose of Kinrix when co-administered with varicella vaccine (Varivax®, Merck and Company) and MMR vaccine (M-M-R®II, Merck and Company), compared to that of a booster dose of Kinrix co-administered with MMR vaccine only, in healthy children 4 to 6 years of age. - DTPA-IPV 055
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 478
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 for whom the investigator believes that their parents/ guardians can and will comply with the requirements of the protocol should be enrolled in the study.
- •A male or female child between 4 and 6 years of age, inclusive.
- •Written informed consent obtained from the parent or guardian of the subject.
- •Healthy subjects as established by medical history and clinical examination before entering into the study.
- •Having received 4 doses of DTaP using Pediarix and/or Infanrix, and 3 doses of poliovirus vaccine using Pediarix and/or IPOL in the first 2 years of life
- •Previously received 1 dose of M-M-RII and Varivax in the second year of life.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 478
- •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 drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period.
- •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 non-investigational product or device.
- •History of previous or intercurrent diphtheria, tetanus, pertussis, polio, measles, mumps, rubella or varicella dis-ease, or of vaccination against these diseases given after the second year of life.
- •Known exposure to diphtheria, tetanus, pertussis, or polio, prior to vaccination.
- •Poliovirus vaccination with one or more doses of OPV vaccine.
- •Administration or planned administration of a vaccine not foreseen by the study protocol within 30 days of study vaccination and ending at Day 30.
- •Chronic administration or planned administration of immu-nosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period ending at Day 30.
- •Administration of immunoglobulins and/or any blood prod-ucts at any time prior to study vaccination or planned ad-ministration during the study period ending at Day 30.
- •Any confirmed or suspected immunosuppressive or im-munodeficient condition, including human immunodeficiency virus infection
- •History of seizures or progressive neurological disorder, including infantile spasms, uncontrolled epilepsy or pro-gressive encephalopathy.
- •Major congenital defects or serious chronic illness.
- •Acute disease at the time of enrolment.
- •History of allergic disease or reactions likely to be exacer-bated by any component of the vaccines, including allergic reactions to formaldehyde, neomycin, polymyxin B, streptomycin, gelatin, and/or latex.
- •History of anaphylactic reaction to egg proteins or previous doses of the vaccines.
- •Encephalopathy within 7 days of administration of previous dose of Infanrix or Pediarix.
- •Fever >= 40.5°C or 104.9°F within 48 hours of previous dose of Infanrix or Pediarix not due to another identifiable cause.
- •Collapse or shock-like state within 48 hours of previous dose of DTaP or DTaP-containing vaccine.
- •Persistent, severe, inconsolable screaming or crying lasting >= 3 hours occurring within 48 hours of administration of previous dose of DTaP or DTaP-containing vaccine.
- •Thrombocytopenia following a previous dose of M-M-RII or its component vaccines
- •Inability to contact a parent/guardian of the subject by telephone.
- •Blood dyscrasias, leukemia, lymphomas or other malignant neoplasms affecting the bone marrow or lymphatic systems.
- •Family history of congenital or hereditary immunodeficiency, unless the immune competence of the subject has been demonstrated.
- •Residence in the same household as the following per-sons:
- •-New-born infants.
- •-Pregnant mother/women without documented posi-tive history of chickenpox disease or laboratory evidence of prior varicella vaccination.
- •-Pregnant women at or beyond 28 weeks gestation regardless of varicella vaccination status or varicella dis-ease history.
- •-Persons with known immunodeficiency.
研究者
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