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 @ 6:41 PM
Ignite Modification Date:
2025-12-24 @ 6:41 PM
NCT ID:
NCT06280157
Eligibility Criteria:
Inclusion Criteria:
1. Women who have participated in study MVX0002, and/or in study MVX0003 with GBS-NN/NN2 vaccine and received 1, 2 or 3 doses of GBS-NN/NN2.
2. Able to voluntarily provide written informed consent to participate in the study.
3. Participant must be fit to participate in the study, as assessed by the investigator.
4. Participant must be able to comply with study procedures and provide at least 2 blood samples.
Exclusion Criteria:
1. Investigator site staff members directly involved in the conduct of the study and their family members, site staff members otherwise supervised by the investigator, or MinervaX employees, including their family members.
2. Any known or suspected immunocompromising or immune suppressive condition (including conditions caused by certain immunocompromising/immunosuppressive medication), unless the condition is expected to normalise within 12 weeks after enrolment. If this is the case, then the subject can be enrolled but the blood sampling will be postponed until the condition has normalised.
3. Received systemic steroids in the 6 weeks before any blood sampling (inhaled and topical steroids are acceptable).
4. Received blood, blood products, plasma derivatives or any immunoglobulin preparations in the 12 weeks before any blood sampling.
5. While participants who are enrolled on this study will also be eligible for participation in other clinical trials which may be ongoing during the overall period of participation in this study, they are not allowed to participate in another vaccine study nor in a study involving a licensed or investigational drug which is known or suspected to have an impact on the immune response (immune compromising/suppressing/stimulating).
Healthy Volunteers:
True
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
40 Years
Study:
NCT06280157
Study Brief:
Protocol Section:
NCT06280157