Prevention of Group B streptococcus infection
Conditions
Brief summary
At 28 days after the third vaccination: o Anti-tetanus toxoid antibody concentration ≥0.1 IU/mL o Anti-diphtheria toxoid antibody concentrations ≥0.1 IU/mL, At 28 days after the third vaccination: o Anti-pertussis toxin antibodies o Anti-FHA antibodies o Anti-PRN antibodies, At 28 days after the third vaccination for Groups 1 and 2; and 28 days after the second vaccination for Groups 3 and 4: o Antibody concentrations for RibN, Alp1N, Alp2N, and AlpCN, Solicited local AEs within 7 days after each dose (ie, the day of dosing + 6 days post-dose), Solicited systemic AEs within 7 days after each dose (ie, the day of dosing + 6 days post-dose), Unsolicited AEs within 28 days after each dose (ie, the day of dosing + 27 days post-dose), SAEs from the first dose to the end of the trial
Detailed description
MAAEs from the first dose to the end of the trial
Interventions
Sponsors
Minervax ApS
Eligibility
Sex/Gender
All
Age
18 Years to 64 Years
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| MAAEs from the first dose to the end of the trial | — |
Primary
| Measure | Time frame |
|---|---|
| At 28 days after the third vaccination: o Anti-tetanus toxoid antibody concentration ≥0.1 IU/mL o Anti-diphtheria toxoid antibody concentrations ≥0.1 IU/mL, At 28 days after the third vaccination: o Anti-pertussis toxin antibodies o Anti-FHA antibodies o Anti-PRN antibodies, At 28 days after the third vaccination for Groups 1 and 2; and 28 days after the second vaccination for Groups 3 and 4: o Antibody concentrations for RibN, Alp1N, Alp2N, and AlpCN, Solicited local AEs within 7 days after each dose (ie, the day of dosing + 6 days post-dose), Solicited systemic AEs within 7 days after each dose (ie, the day of dosing + 6 days post-dose), Unsolicited AEs within 28 days after each dose (ie, the day of dosing + 27 days post-dose), SAEs from the first dose to the end of the trial | — |
Countries
Belgium, Poland
Outcome results
None listed