EUCTR2021-003214-40-DK进行中（未招募）1 期
A multicentre, multinational, parallel group, observer-blind, randomised, placebo-controlled study on the Group B Streptococcus vaccine (GBS-NN/NN2), investigating the immunogenicity and safety of four vaccination regimens in pregnant woman, assessing IgG specific to AlpN proteins in cord blood and maternal blood, and the safety profile in mother and infant up to 6 months post-delivery
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- MinervaX Aps
- 入组人数
- 270
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
- Female
入选标准
- •1. Healthy pregnant woman above the legally defined age of consent at the time of screening
- •2. Carrying a normal singleton pregnancy and is at 21+0 to 23+6 weeks GA at the planned time of the 1st vaccination, as established by first/second trimester ultrasound examination
- •3. Properly informed about the study and has given written informed consent and parental consent (for her baby) in accordance with ICH GCP and local legislation prior to the first study intervention
- •4. Grants access to her own and her baby’s study related medical records
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 270
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 270
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Previous vaccination with an investigational Group B Streptococcus (GBS) Vaccine
- •2. BMI of <17 or >40 at the time of screening
- •3. HIV, HBV and/or HCV positive or positive for syphilis
- •4. Knowingly carrying, at screening, a malformed or genetically abnormal foetus, incl. renal pelvis dilation, single umbilical artery (screening will be undertaken after the ultrasound conducted for the detection of anomalies)
- •5. Chronic or pregnancy induced hypertension at screening, >1+ protein in urine regardless of blood pressure or 1+ protein in urine and hypertension
- •6. Experienced a previous stillbirth prior to going into labour
- •7. Gestational, type 1 or type 2 diabetes
- •8. Potential placenta previa as per malformation ultrasound scan
- •9. Rhesus negative and has anti-D antibodies or other potential harmful antibodies
- •10. Known or suspected allergies to any components of the vaccine including to aluminium or aminoglycoside antibiotics, or an allergic reaction related to a previous vaccination
- •11. Fever (temperature >37.9°C) on the day of receiving the first dose or an acute infection in the 7 days before the first dose (the first dose can be delayed if gestational age permits)
- •12. Received systemic steroids in the 6 weeks before the first dose (inhaled and topical steroids are acceptable)
- •13. Any lesion (including tattoos) at the planned injection site that will impair the assessment of the injection site.
- •14. Received immunosuppressive medication, chemotherapy or radiotherapy in the 24 weeks before the first dose
- •15. Received blood, blood products, plasma derivatives or any immunoglobulin preparations in the 12 weeks before the first dose
- •16. Anaemia, haemoglobin (<10 g/dL, 100 g/L, 6.2 mmol/L)
- •17. Currently breast feeding
- •18. Received any investigational medicinal product or vaccine in the 12 weeks or 5 half-lives before the first dose
- •19. Received an approved vaccine within the 4 weeks before the first dose or expects to receive an approved vaccine during the study. (Routine vaccinations recommended during pregnancy (e.g., pertussis and influenza) are permitted but every effort should be made to separate routine vaccinations from the trial vaccinations by at least 7 days.)
- •20. Known or suspected immunodeficiency or cancer (leukaemia, lymphoma), or a family history of congenital or hereditary immunodeficiency
- •21. History or presence of uncontrolled cardiovascular disease, pulmonary, hepatic, gall bladder or biliary tract, renal, haematological, gastrointestinal, endocrine, immunologic, dermatological, neurological, psychiatric, or autoimmune disease
- •22. History of, or current drug or alcohol abuse
- •23. In the opinion of the investigator not suitable for inclusion in the study
- •24. The pregnancy is considered high risk by treating physicians
研究者
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