EUCTR2012-004221-25-ES进行中（未招募）不适用
A phase 3 open-label study to evaluate the immunogenicity and safety of a mixed (HEXA/PENTA/HEXA) primary series schedule that includes V419 (PR5I) at 2 and 6 months of age and Pediacel® at 4 months of age. - Spanish mixed HEXA/PENTA/HEXA schedule
Sanofi Pasteur MSD0 个研究点目标入组 385 人开始时间: 2013年1月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 385
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
- •1.Subject is a healthy infant greater than or equal to 46 days and less than or equal to 74 days of age on the day of inclusion.
- •2.Subject has received only one dose of monovalent hepatitis B vaccine, within the 3 days after birth, outside of the study context and it is documented in subject´s medical history.
- •3.Informed consent has been signed by the subject's parent(s) or legal representative.
- •4.Subject's parent(s) or legal representative able to comply with the study procedures such as adherence to study visits and completion of the Vaccination Report Cards.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 385
- •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
- •1.Participation in any study with an investigational compound or device since birth
- •2.Subject´s parent(s)/legal representative plans to enrol the subject in another clinical study during the present study period
- •3.History of congenital or acquired immunodeficiency (e.g. HIV)
- •4.Chronic illness that could interfere with study conduct or completion, or significant findings on review of systems (by medical history) such as development delay or neurological disorder
- •5.Known or suspected hypersensitivity to any of the study vaccines' components or history of a life-threatening reaction to a vaccine containing the same substances as the study vaccines
- •6.Contraindication to Pediacel®, NeisVac-C®, Prevenar 13®, and RotaTeq® as per their Summary of Product Characteristics
- •7.History or maternal history of HBsAg seropositivity
- •8.Coagulation disorder that contraindicate intramuscular injection
- •9.History of vaccination with a Haemophilus influenzae type b conjugate, diphtheria, tetanus, pertussis (acelullar or whole-cell), poliovirus, meningococcal serogroup C conjugate, pneumococcal conjugate containing vaccine(s)
- •10.History of hepatitis B, Haemophilus influenzae type b, diphtheria, tetanus, pertussis, poliomyelitis, or serogroup C meningococcal infection
- •11.Receipt of immune globulin, blood or blood-derived products since birth
- •12.Receipt of systemic corticosteroids (greater than the equivalent of 2 mg/kg total daily dose of prednisone) for more than 14 consecutive days within one month of the study start
- •13.Subjects expected to require systemic corticosteroids (greater than the equivalent of 2 mg/kg total daily dose of prednisone) for more than 14 consecutive days from the time of study start through the end of the safety follow-up period following the last dose. Subjects using non-systemic corticosteroids (e.g. topical, ophthalmic, and inhaled) will be eligible for vaccination.
- •14.Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
研究者
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