CTRI/2024/07/070928尚未招募2 期
A Phase II, Randomized, Double-blind Trial to Assess the Safety and Immunogenicity of MTBVAC (BBV169), with BCG vaccine as a comparator in Healthy adolescent and adult populations - Nil
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Ability to provide written informed consent and informed Assent from Adolescents 2. Participants of either gender of age between =12 to =65 years at the time of obtaining informed consent.
- •3. Good general health as determined by the discretion of the investigator (vital signs, medical history, and physical examination).
- •4. Expressed interest and Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol.
- •5. For a female participant of childbearing potential, planning to avoid pregnancy (use of an effective method of contraception or abstinence) from the time of study enrolment until at least 3 months after IP administration.
- •6. Male participants of reproductive potential: Willing to use condoms to ensure effective contraception with the female partner from IP administration until 3 months.
- •7. No evidence of active TB disease during screening – As confirmed by Truenat test. 8. A negative urine pregnancy test for female participants of childbearing potential.
- •9. Only participants who are HIV negative
- •10. Non-Diabetic participants with RBS less than 140 mg/dl and as confirmed by medical history
- •11. Had BCG vaccination, documented through presence of scar.
排除标准
- •1. Any chronic febrile illness with oral temperature Greater Than 100.4°F on the day of
- •randomization.
- •2. Clinical evidence of pulmonary pathology.
- •3. History of any form of TB Disease.
- •4. Prior or present anti-TB treatment
- •5. Received Tuberculin Skin Test (TST) within 3 months (90 days) prior to Study
- •6. Clinical evidence of Active TB
- •7. Participants with household contacts of patients with active TB disease
- •8. History of allergic reactions (significant IgE-mediated events) or anaphylaxis to
- •previous immunizations (any vaccine).
- •9. History of allergic disease or reactions.
- •10. History of previous administration of experimental TB vaccines.
- •11. Use of any investigational or non-registered product (drug or vaccine) in another
- •experimental protocol other than the trial vaccines within 30 days preceding the
- •vaccination, or planned use during the trial period.
- •12. Any chronic drug therapy to be continued during the trial period.
- •13. Chronic administration of immunosuppressors or other immune-modifying drugs.
- •14. Administration of any immunoglobulins, any immunotherapy, and/or any blood
- •products within the three months preceding the vaccination, or planned
- •administrations during the trial period.
- •15. Any confirmed or suspected immunosuppressive or immunodeficient condition
- •based on medical history and physical examination.
- •16. Participant who are HIV Positive or on ART.
- •17. Participants with a medical history of diabetes or those whose RBS levels exceed
- •18. Any condition or history of any acute or chronic illness or medication, which, in
- •the opinion of the Investigator, may interfere with the evaluation of the trial
- •objectives.
- •19. A family history of congenital or hereditary immunodeficiency
- •20. History of any neurologic disorders or seizures.
- •21. History of chronic alcohol consumption and/or drug abuse.
- •22. Congenital defects in cardio pulmonary and neurological system
- •23. Pregnant or lactating female.
- •24. Female planning to become pregnant or planning to discontinue contraceptive
- •precautions during the trial period.
- •25. Those who have been vaccinated with live attenuated vaccines within 30 days of
- •trial vaccine administration and those who are planning to take live attenuated
- •vaccine within 30 days after trial vaccine administration.
- •26. Administration of any vaccines that are not live attenuated within 30 days before
- •trial vaccine administration.
研究者
相似试验
进行中（未招募）
1 期
A Randomized, Double-blind, Phase 2 Trial to assess how safe and how efficacious Lenvatinib is at two different starting doses (18 mg vs. 14 mg QD) when it is given in Combination with Everolimus (5 mg once a day ) in patients with Renal cancer that have already had one VEGF-Targeted TreatmentAdvanced renal cell carcinomaMedDRA version: 20.0Level: PTClassification code 10038389Term: Renal cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)MedDRA version: 20.0Level: LLTClassification code 10038409Term: Renal cell carcinoma NOSSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)EUCTR2016-002778-11-ESEisai Ltd306
进行中（未招募）
1 期
A randomized, double-blind phase II trial to assess the efficacy and safety of bicalutamide (Casodex® ) associated to ZD6474 (Zactima™ ) or to placebo in patients with castration-refractory metastatic prostate cancer without any clinical symptom related to disease progression.MedDRA version: 9.1Level: LLTClassification code 10036909Term: Prostate cancer metastaticMetastatic prostate cancerEUCTR2007-001891-35-FRAstraZeneca SAS90
进行中（未招募）
不适用
A Phase II, Double-Blind, Randomised Study to Assess the Efficacy of AZD6244 (Hyd-Sulfate) in Combination with Dacarbazine Compared with Dacarbazine Alone in First Line Patients with BRAF Mutation Positive Advanced Cutaneous or Unknown Primary MelanomaBRAF mutation positive advanced cutaneous and unknown primary melanomaMedDRA version: 9.1Level: LLTClassification code 10025654Term: Malignant melanoma of sites other than skinMedDRA version: 9.1Level: LLTClassification code 10025670Term: Malignant melanoma stage IIIMedDRA version: 9.1Level: LLTClassification code 10025671Term: Malignant melanoma stage IVMedDRA version: 9.1Level: LLTClassification code 10027152Term: Melanoma of skin (malignant)MedDRA version: 9.1Level: LLTClassification code 10027480Term: Metastatic malignant melanomaEUCTR2008-006344-19-HUAstraZeneca AB
进行中（未招募）
1 期
A Phase II, Double-Blind, Randomised Study to Assess the Efficacy of AZD6244 (Hyd-Sulfate) in Combination with Dacarbazine Compared with Dacarbazine Alone in First Line Patients with BRAF Mutation Positive Advanced Cutaneous or Unknown Primary MelanomaBRAF mutation positive advanced cutaneous and unknown primary melanomaMedDRA version: 9.1Level: LLTClassification code 10025654Term: Malignant melanoma of sites other than skinMedDRA version: 9.1Level: LLTClassification code 10025670Term: Malignant melanoma stage IIIMedDRA version: 9.1Level: LLTClassification code 10025671Term: Malignant melanoma stage IVMedDRA version: 9.1Level: LLTClassification code 10027152Term: Melanoma of skin (malignant)MedDRA version: 9.1Level: LLTClassification code 10027480Term: Metastatic malignant melanomaEUCTR2008-006344-19-CZAstraZeneca AB91
进行中（未招募）
1 期
A Phase II, Double-Blind, Randomised Study to Assess the Efficacy of AZD6244 (Hyd-Sulfate) in Combination with Dacarbazine Compared with Dacarbazine Alone in First Line Patients with BRAF Mutation Positive Advanced Cutaneous or Unknown Primary MelanomaBRAF mutation positive advanced cutaneous and unknown primary melanomaMedDRA version: 9.1 Level: LLT Classification code 10025654 Term: Malignant melanoma of sites other than skinMedDRA version: 9.1 Level: LLT Classification code 10025670 Term: Malignant melanoma stage IIIMedDRA version: 9.1 Level: LLT Classification code 10025671 Term: Malignant melanoma stage IVMedDRA version: 9.1 Level: LLT Classification code 10027152 Term: Melanoma of skin (malignant)MedDRA version: 9.1 Level: LLT Classification code 10027480 Term: Metastatic malignant melanomaEUCTR2008-006344-19-GBAstraZeneca AB91