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A follow-up trial of GBS NN/NN2 vaccine in healthy pregnant women
EU CTIS ID: 2024-516364-28-00
What this study is testing
To evaluate the persistence of the IgG antibody responses, after a primary vaccination with GBS NN/NN2 in all participants
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Participant living in Denmark or South Africa who has participated in Trial MVX0004 and has received at least 1 dose of the GBS-NN/NN2 vaccine
- 2. Participant who is able to read and understand and capable of giving personal signed informed consent
- 3. Participant who is willing and able to comply with scheduled visits, the investigational plan, and other trial procedures
- 4. Participant who is granting access to their trial-related medical records and to their trial materials from Trial MVX0004, whatever is applicable
- 5. Participant who is expected to be available for the duration of the trial and who can be contacted by telephone during trial participation.
You likely can't join if
- 1. Any personnel involved in the conduct of the trial (and their family members), including, but not limited to, site staff members, MinervaX employees, and any vendor or contract research organisation employees
- 2. Participant with confirmed Group B Streptococcus (GBS) infection since participation in Tria l MVX0004
- 3. Participant with any psychiatric condition, including recent (within the past year) active suicidal ideation/behaviour that may increase the risk of trial participation or, in the investigator’s judgement, make the participant unsuitable for participation in the trial
- 4. Participant who participated in other trials involving investigational drug(s) or devices within 28 days prior to trial entry, and/or are participating in other trials involving investigational drug(s) or devices at trial entry, or plan to (continue to) participate in other trials involving investigational drug(s) or devices during this trial;
- 5. Participant with known or suspected immunodeficiency or cancer or a family history of congenital or hereditary immunodeficiency
- 6. Participant receiving chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to trial entry. An immunosuppressive dose of glucocorticoid will be defined as a systemic dose ≥10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted
See the full eligibility criteria
Who can join
- 1. Participant living in Denmark or South Africa who has participated in Trial MVX0004 and has received at least 1 dose of the GBS-NN/NN2 vaccine
- 2. Participant who is able to read and understand and capable of giving personal signed informed consent
- 3. Participant who is willing and able to comply with scheduled visits, the investigational plan, and other trial procedures
- 4. Participant who is granting access to their trial-related medical records and to their trial materials from Trial MVX0004, whatever is applicable
- 5. Participant who is expected to be available for the duration of the trial and who can be contacted by telephone during trial participation.
What rules you out
- 1. Any personnel involved in the conduct of the trial (and their family members), including, but not limited to, site staff members, MinervaX employees, and any vendor or contract research organisation employees
- 2. Participant with confirmed Group B Streptococcus (GBS) infection since participation in Tria l MVX0004
- 3. Participant with any psychiatric condition, including recent (within the past year) active suicidal ideation/behaviour that may increase the risk of trial participation or, in the investigator’s judgement, make the participant unsuitable for participation in the trial
- 4. Participant who participated in other trials involving investigational drug(s) or devices within 28 days prior to trial entry, and/or are participating in other trials involving investigational drug(s) or devices at trial entry, or plan to (continue to) participate in other trials involving investigational drug(s) or devices during this trial;
- 5. Participant with known or suspected immunodeficiency or cancer or a family history of congenital or hereditary immunodeficiency
- 6. Participant receiving chronic administration (defined as more than 14 continuous days) of immunosuppressants or other immune-modifying drugs within 6 months prior to trial entry. An immunosuppressive dose of glucocorticoid will be defined as a systemic dose ≥10 mg of prednisone per day or equivalent. The use of topical, inhaled, and nasal glucocorticoids will be permitted
- 7. Participant who received blood, blood products, plasma derivatives, or any immunoglobulin preparations in the 12 weeks prior to trial entry or is planning to receive such products during this trial
- 8. Participant with current or history of drug or alcohol abuse, as judged by the investigator
- 9. Participant who received any marketed or investigational (other than GBS-NN/NN2 in Trial MVX0004) GBS vaccines or who is planning to receive any marketed or investigational (other than GBS-NN/NN2) GBS vaccines during this trial.
The study team makes the final eligibility decision.
Where it's taking place
- South Africa
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18-64 years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include South Africa. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.