Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:29 PM
Ignite Modification Date:
2025-12-24 @ 10:29 PM
NCT ID:
NCT05571735
Eligibility Criteria:
Inclusion Criteria:
* 18 years and above, newly diagnosed bacteriologically confirmed TB patients including both drug sensitive and resistant TB, who are taking anti TB or MDR-TB treatment in initial period during study period or clinically healthy individuals for comparator arm.
* Willing to be followed for four weeks following second dose of Pfizer-BioNTech COVID-19 vaccine and AstraZeneca vaccine or eight weeks following single dose of Janssen Ad26.COV2.S COVID-19 vaccine
* Willing to be involved in the pre-enrolment screening.
* For women with child bearing potential only (aged 18-49 years), willing to continue to use effective contraception methods through the study.
* For women with child bearing potential only (aged 18-49 years), negative pregnancy test on the day of screening and on the day of vaccination to be eligible to receive the vaccination.
* Able and willing to comply with all study requirements.
* Ability to understand the study instructions and provide written informed consent
Exclusion Criteria:
* History of laboratory confirmed COVID-19 for any duration before or positive COVID-19 PCR or antigenic test at screening.
* History of HIV infection
* Participation in other COVID-19 related studies for the duration of the study.
* Participation in other vaccine trials within 90 days before and 30 days after the study vaccination.
* Administration of any immunoglobulins or any type of COVID-19 vaccine within 90 days before administration of the vaccine.
* History of allergic disease or reactions likely to be exacerbated by any component of the vaccine.
* Any previous history of a serious side effect with any kind of vaccine.
* Any history of angioedema.
* Any history of anaphylaxis.
* Women with pregnancy, lactation or planning to get pregnant during the duration of the study.
* Current diagnosis of or treatment for cancer.
* History of severe psychiatric disorders likely to affect participation in the study.
* Bleeding disorder (e.g. coagulation factor deficiency, coagulopathy or platelet disorder), history of thrombosis or prior history of significant bleeding or bruising following IM injections or venipuncture.
* Suspected or known current alcohol or drug dependency (except well controlled condition).
* Presence of any condition which in the judgement of the investigator would place the patient at undue risk or interfere with the results of the study.
* Severe and/or uncontrolled cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorder and neurological illness (mild/moderate well controlled comorbidities are allowed).
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05571735
Study Brief:
Protocol Section:
NCT05571735