EUCTR2019-002585-12-IT进行中（未招募）1 期
Immunogenicity and Safety of DTaP-IPV-HB-PRP~T Combined Vaccine Given at 3, 5, and 12 Monhs of Age Concomitantly or Sequentially 4CMenB Vaccine in Italian Infants - NA
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 396
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
- •- Aged 76 to 110 days on the day of the first study visit (depending on local practices as per National Immunization Program (NIP))
- •- Born to an adult mother (>= 18 years of age) (including mothers vaccinated and not vaccinated with Tdap during pregnancy)
- •- Born at full term of pregnancy (>= 37 weeks) and with a birth weight >= 2.5 kg or born after a gestation period of 32 through 37 weeks with a birth weight >= 2.0 kg and under stable condition defined as: infant who does not require significant medical support or ongoing management for debilitating disease and who have demonstrated a sustained recovery growth curve by the time he/she receives the first dose of the vaccination series
- •- Participant and parent(s)/legally acceptable representative(s) 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:
- •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 at the time of study enrollment (or in the 4 weeks preceding the first trial vaccination) or planned participation during the present trial period in another clinical trial investigating a vaccine, drug, medical device, or medical procedure
- •2. Receipt of any vaccine in the 4 weeks preceding the first trial vaccination or planned receipt of any vaccine in the 4 weeks following any trial vaccination, except in case of routine vaccines to be administered as per the NIP and for influenza vaccination. This exception includes monovalent pandemic influenza vaccines and multivalent influenza vaccines
- •3. Previous vaccination against diphtheria, tetanus, pertussis, poliomyelitis, hepatitis B (Hep B), pneumococcal, meningococcal, or Hib infections or diseases with the study vaccine or another vaccine
- •4. Receipt of immunoglobulins, blood or blood-derived products since birth
- •5. 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 corticosteroid therapy (prednisone or equivalent for more than 2 consecutive weeks since birth)
- •6. Known personal or maternal history of Hep B (HBsAg) or Hep C seropositivity
- •7. History of diphtheria, tetanus, pertussis, poliomyelitis, Hep B, Hib infection, meningococcal infection, or pneumococcal infection, confirmed either clinically, serologically or microbiologically
- •8. Known systemic hypersensitivity to latex or to any of the vaccine components, or history of a life-threatening reaction to the vaccine(s) used in the trial or to a vaccine containing any of the same substances
- •9. Known thrombocytopenia, as reported by the parent(s)/legally acceptable representative(s) contraindicating intramuscular (IM) vaccination as assessed by the investigator
- •10. Bleeding disorder, or receipt of anticoagulants in the 3 weeks preceding inclusion, contraindicating IM vaccination
- •11. History of seizures
- •12. Participants in an emergency setting or hospitalized involuntarily
- •13. Chronic illness that, in the opinion of the investigator, is at a stage where it might interfere with trial conduct or completion
- •14. Moderate or severe acute illness/infection (according to investigator judgment) on the day of vaccination or febrile illness (axillary temperature >= 38.0°C [>= 100.4°F]). A prospective participant should not be included in the study until the condition has resolved or the febrile event has subsided
- •15. 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）
1 期
Study to Assess the Immune Response and the Safety Profile of DTaP-IPV-HB-PRP~T Combined Vaccine Given Concomitantly or Sequentially with 4CMenB Vaccine in Italian and Finnish 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-FISanofi Pasteur200
未知
3 期
Immunogenicity and Safety of the DTaP-IPV (sanofi Pasteur Kitasato) Combined Vaccine (DD-687) given subcutaneously as a three-dose primary and booster vaccination versus commercially available DTaP (Kitasato) and Oral Polio Virus (OPV) Vaccines in Infants in JapaProphylaxis of pertussis, diphtheria, tetanus, and poliomyelitis infection.JPRN-jRCT2080221313DAIICHISANKYO Co.,Ltd., Sanofi Aventis KK374
已完成
不适用
Study of DTaP-IPV-Hep B-PRP~T Combined Vaccine Compared to Infanrix®Hexa in Healthy Peruvian Infants-Z278 Need for immunisation against other combinations of infectious diseasesNeed for immunisation against other combinations of infectious diseasesZ278PER-120-07SANOFI PASTEUR S.A.,
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
3 期
DTaP-IPV-Hep B-PRP~T Combined Vaccine Versus DTaP-IPV//PRP~T Combined Vaccine + Hep B Vaccine in Hep B Primed InfantsHaemophilus Influenzae Type b InfectionPoliomyelitisPertussisHepatitis BTetanusDiphtheriaNCT02094833Sanofi Pasteur, a Sanofi Company310