EUCTR2015-005404-29-Outside-EU/EEA进行中（未招募）不适用
Safety of the DTacP-IPV//PRP~T Combined Vaccine (PENTAXIM®) Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in China
SANOFI PASTEUR SA0 个研究点目标入组 900 人开始时间: 2015年12月4日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 900
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
- •An individual must fulfill all of the following criteria in order to be eligible for trial enrollment:
- •1) Aged 2 months (60 to 74 days) inclusive on the day of the first study visit
- •2) Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative
- •3) Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 900
- •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
- •An individual fulfilling any of the following criteria is to be excluded from trial enrollment:
- •1) Participation or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- •2) Known or suspected congenital or acquired immunodeficiency; or receipt of immunosuppressive therapy, such as anti-cancer chemotherapy or radiation therapy since birth, or long-term systemic corticosteroids therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
- •3) Known systemic hypersensitivity to any of the vaccine components, or history of a life-threatening reaction to the vaccine used in the trial or to a vaccine containing any of the same substances
- •4) Clinically significant illness, according to investigator judgment, at a stage that could interfere with trial conduct or completion
- •5) Evolving encephalopathy
- •6) Receipt of immune globulins, blood or blood–derived products since birth
- •7) Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection
- •8) Receipt of any other vaccine in the 14 days preceding the first trial vaccination or planned receipt of any vaccine in the 14 days following the first trial vaccination
- •9) Acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature =37.1°C). A prospective subject should not be included in the study until the condition has resolved or the febrile event has subsided.
- •10) Contraindications to vaccination according to PENTAXIM® summary of product characteristics (SPC) or leaflet
- •11) In an emergency setting, or hospitalized involuntarily
- •12) Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study
研究者
相似试验
进行中（未招募）
不适用
Immunogenicity and Safety of Pentaxim as 3 Doses Primary Vaccination Followed by a Booster Dose at 18 MonthsHealthy volunteers: active immunization against diphtheria, tetanus, pertussis, poliomyelitis and invasive infections caused by Haemophilus influenzae type b (such as meningitis, septicaemia, cellulitis, arthritis, epiglottitis, pneumopathy, osteomyelitis)MedDRA version: 18.1Level: LLTClassification code 10036897Term: Prophylactic vaccinationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 18.1Level: HLGTClassification code 10043413Term: Therapeutic procedures and supportive care NECSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 18.1Level: PTClassification code 10021430Term: ImmunisationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 18.1Level: HLTClassification code 10021431Term: ImmunisationsSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2015-005353-12-Outside-EU/EEASANOFI PASTEUR SA792
已完成
4 期
Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in ChinaPolioTetanusDiphtheriaPertussisNCT01491087Sanofi Pasteur, a Sanofi Company900
已完成
3 期
Vaccine -diphthEria -tetaNus -Acellular pertUssis-inactivated polioviruSPoliomyelitisPertussisTetanusDiphtheriaNCT02458183Boryung Pharmaceutical Co., Ltd476
已完成
3 期
Safety of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Tritanrix-HepB/Hib™ and OPV Given at Age 2, 4, and 6 Months.Haemophilus Influenzae Type bHepatitis BTetanusPertussisDiphtheriaNCT00313911Sanofi Pasteur, a Sanofi Company2,133
进行中（未招募）
1 期
Study to Assess the Immune Response and the Safety Profile of DTaP-IPVHB- PRP~T Combined Vaccine Given Concomitantly or Sequentially with 4CMenB Vaccine in Italian InfantsHaemophilus influenzae type b immunisationMedDRA version: 21.1Level: LLTClassification code 10054181Term: Hepatitis B immunizationSystem Organ Class: 10042613 - Surgical and medical proceduresMedDRA version: 21.1Level: PTClassification code 10069533Term: Haemophilus influenzae type b immunisationSystem Organ Class: 10042613 - Surgical and medical proceduresEUCTR2019-002585-12-ITSANOFI PASTEUR396