NCT01491087已完成4 期
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
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 3
- 主要终点
- Description of the Safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with PENTAXIM® vaccine
研究概览
简要总结
The study will assess the safety of Pentaxim® vaccine as a three-dose primary vaccination at 2, 3, and 4 months of age in order to meet the regulatory requirements for the license renewal as for any other product registered in China, and to generate additional clinical data using the three-dose primary vaccination schedule in some other Chinese provinces.
Primary Objective
- To describe the safety after administration of PENTAXIM® at 2, 3, and 4 months of age in the study population.
详细描述
Each study participant will receive an injection of PENTAXIM® at 2, 3, and 4 months of age and will be monitored for safety through the entire study period.
The duration of each participant in the trial will be approximately 3 to 4 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 60 Days 至 74 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Aged 2 months (60 to 74 days) inclusive on the day of the first study visit
- •Informed consent form has been signed and dated by the parent(s) or other legally acceptable representative
- •Subject and parent/legally acceptable representative are able to attend all scheduled visits and to comply with all trial procedures.
排除标准
- •Participation or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- •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)
- •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
- •Clinically significant illness, according to investigator judgment, at a stage that could interfere with trial conduct or completion
- •Evolving encephalopathy
- •Receipt of immune globulins, blood or blood-derived products since birth
- •Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis diseases or Haemophilus influenzae type b infection
- •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
- •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.
- •Contraindications to vaccination according to PENTAXIM® summary of product characteristics (SPC) or leaflet
- •In an emergency setting, or hospitalized involuntarily
- •Identified as a natural or adopted child of the Investigator or employee with direct involvement in the proposed study.
结局指标
主要结局
Description of the Safety profile in terms of solicited injection site and systemic reaction, and serious adverse events after each vaccination with PENTAXIM® vaccine
时间窗: Day 0 for up to 3 months post vaccination
Solicited injection site: Tenderness, Redness, and Swelling. Solicited Systemic reaction: Fever (Temperature), Vomiting, Abnormal crying, Drowsiness, Loss of Appetite, and Irritability
次要结局
未报告次要终点
研究者
研究点 (3)
Loading locations...
相似试验
进行中（未招募）
不适用
Safety of PENTAXIM® Given as a Three-Dose Primary Vaccination at 2, 3, and 4 Months of Age in Infants in ChinaHealthy 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 proceduresEUCTR2015-005404-29-Outside-EU/EEASANOFI PASTEUR SA900
Unknown
3 期
To Evaluate the Immunogenicity and Safety of DTaP-IPV Vaccine Administered as a Boosting Dose to Healthy Children of 4-6 YearsPoliomyelitisDiphtheriaTetanusPertussisNCT04618640Boryung Biopharma Co., Ltd.249
已完成
3 期
Safety and Immunogenicity of 20vPnC in Toddlers With 2 Prior Doses of Prevenar 13Pneumococcal DiseaseNCT05408429Pfizer356
已完成
3 期
Safety Study of GSK Biologicals' DTPa-IPV/Hib (Infanrix™-IPV/Hib)Haemophilus Influenzae Type bAcellular PertussisPoliomyelitisTetanusDiphtheriaNCT00964028GlaxoSmithKline50
已完成
3 期
Study to Assess Safety & Immunogenicity of GSK Biologicals' DTPa/Hib Vaccine vs Separate Administration of DTPa and Hib.Acellular PertussisTetanusDiphtheriaNCT00412854GlaxoSmithKline660