Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women (NCT05154578) | Clinical Trial Compass
CompletedPhase 2
Immunogenicity and Safety of GBS-NN/NN2 in Pregnant Women
Denmark, South Africa269 participantsStarted 2022-02-17
Plain-language summary
This is a phase II, multicentre, multinational, randomized, parallel group, placebo-controlled study of four vaccination regimens in healthy pregnant women. There will be 5 treatment groups; three groups of 60 participants will receive will receive two doses of GBS-NN/NN2 vaccine and one dose of placebo (saline); one group of 60 participants will receive one dose of GBS-NN/NN2 vaccine and two doses of placebo (saline), and one group of 30 participants will receive three doses of placebo (saline).
Who can participate
SexFEMALE
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Inclusion criteria
✓. Healthy pregnant woman above the legally defined age of consent at the time of screening
✓. Carrying a normal singleton pregnancy, and is at 21+0 to 23+6 weeks GA at the planned tme of the 1st vaccination, as established by first/second trimester ultrasound examination
✓. Properly informed about the study and has given written informed consent and parental consent (for her baby) in accordance with the International Conference on Harmonization Good Clinical Practice (ICH GCP) and local legislation prior to the first study intervention
✓. Grants access to her own and her baby's study related medical records
Exclusion criteria
✕. Previous vaccination with an investigational Group B Streptococcus (GBS) Vaccine
✕. BMI of \<17 or \>40 at the time of screening
✕. Human immunodeficiency virus (HIV), hepatitis B virus (HBV) and/or hepatitis C virus (HCV) positive or positive for syphilis
✕. Knowingly carrying, at screening, a malformed or genetically abnormal foetus, incl. renal pelvis dilation, single umbilical artery (screening will be undertaken after the ultrasound conducted for the detection of anomalies)
✕. Chronic or pregnancy induced hypertension at screening, \>1+ protein in urine regardless of blood pressure or 1+ protein in urine and hypertension
✕. Experienced a previous stillbirth prior to going into labour
What they're measuring
1
Concentrations of Immunoglobulin (Ig) G Antibodies Specific to the AlpN Proteins in μg/mL in Cord Blood From Each Baby