A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women (NCT06592586) | Clinical Trial Compass
Active — Not RecruitingPhase 2/3
A Follow-up Trial of GBS-NN/NN2 Vaccine in Healthy Pregnant Women
Denmark, South Africa338 participantsStarted 2025-03-07
Plain-language summary
The main objective of the study is to evaluate the persistence of the immunoglobulin G (IgG) antibody responses, specific to Alpha-like protein CN (AlpCN), Ribosomal Protein N (RibN), Alpha-like protein 1N (Alp1N), and Alpha-like protein 2 and 3 (Alp2-3N), after a primary vaccination with GBS-NN/NN2 in all participants.
Who can participate
Age range18 Years
SexFEMALE
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Inclusion Criteria:
* Participant living in Denmark or South Africa who has participated either in Trial MVX0004 (NCT05154578) or MVX0005 (NCT04596878) and has received at least 1 dose of the GBS-NN/NN2 vaccine.
* Participant who is able to read and understand and capable of giving personal signed informed consent.
* Participant who is willing and able to comply with scheduled visits, the investigational plan, and other trial procedures.
* Participant who is granting access to their trial-related medical records and to their trial materials from Trials MVX0004 or MVX0005, whatever is applicable.
* Participant who are expected to be available for the duration of the trial and who can be contacted by telephone during trial participation.
Exclusion Criteria:
* 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 (CRO) employees.
* Participant with confirmed Group B Streptococcus (GBS) infection since participation in Trial MVX0004 or MVX0005.
* 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.
* Participant who participated in other trials involving investigational drug(s) or devices within 28 days prior to trial ent…
What they're measuring
1
All Participants: Concentration of IgG Antibodies to AlpN Proteins in Blood Serum