This study will evaluate the safety and immunogenicity of a Group B Streptococcus vaccine at one dose in healthy non pregnant women and then in three different doses in healthy pregnant women.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
380
Subjects received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.
Subjects received two injection of saline solution.
Subjects received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
Chris Hani Baragwanath Hospital
Chris Hani Rd, Soweto, Johannesburg, South Africa
The Percentages of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination.
The percentages of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses administered one month apart. Defined thresholds for antibody concentrations, which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Time frame: Day 61, one month after the second vaccination
Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination.
Antibody GMC per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .
Time frame: Day 61, one month after the second vaccination
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype following the administration of one of three different doses of the study vaccine or placebo.Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
Time frame: Day of delivery
Antibody GMC in Maternal Subjects at Day of Delivery
Antibody GMC per serotype in maternal subjects at day of delivery following one administration of one of three different doses of the study vaccine or placebo are reported.
Time frame: Day of delivery
The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination.
The percentages of maternal subjects with antibody concentrations above a defined threshold per serotype at one month after the administration of one of three different doses of the study vaccine or placebo. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 μg/mL.
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Subjects received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
Subjects received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
Subjects received one injection of saline solution.
Time frame: Day 31, one month after vaccination
Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination
Antibody GMC per serotype in maternal subjects at one month after the administration of one of three different doses of the study vaccine or placebo.
Time frame: day 31
The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination.
The percentage of non-pregnant subjects with antibody concentrations above a defined threshold per serotype after the administration of two vaccine doses one month apart. Antibody concentrations which exceed pre-defined serotype specific ELISA values are 1, 2, 3, 5 and 8 mcg/mL.
Time frame: Day 361, one year after the first vaccination
Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination
Antibody GMC per serotype in non-pregnant subjects after receiving two doses of the study vaccine administered one month apart, at one year after first vaccination.
Time frame: Day 361, one year after the first vaccination
Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events
Number of non-pregnant subjects reporting solicited and unsolicited adverse events following 2 injections (1 month apart) of the trivalent GBS vaccine at a dose of 20/20/20 μg with aluminum at one month after second vaccination are reported.
Time frame: Day 61
Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events
Number of maternal subjects reporting solicited and unsolicited adverse events following the administration of either one of three different doses of the study vaccine or placebo.
Time frame: From day 1 to one year after delivery
Antibody GMC Per Serotype at Different Time Points in Infants
Antibody GMC per serotype on the day of birth, at 6 weeks and 3 months of age in infants born from women who received either one of three different doses of the study vaccine or placebo.
Time frame: Day 4, day 43 and day 91 after birth
Number of Infants Reporting Serious Adverse Events
Number of infants born from women who received either one of three different doses of the study vaccine or placebo who reported serious adverse events
Time frame: one year after birth