Streptococcal Infections Clinical Trial
Official title:
A Phase Ib/II Randomized, Observer-Blind, Controlled, Single Centre Study of a Trivalent Group B Streptococcus Vaccine in Healthy Non-Pregnant Women Leading Into a Dose-Ranging Study in Pregnant Women in South Africa
Verified date | August 2014 |
Source | Novartis |
Contact | n/a |
Is FDA regulated | No |
Health authority | South Africa: Medicines Control Council (MCC) |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 380 |
Est. completion date | December 2012 |
Est. primary completion date | December 2011 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years to 40 Years |
Eligibility |
Inclusion Criteria: - Group 1 (Non Pregnant Women): Healthy females 18-40 years of age inclusive. - Group 2 (Healthy Pregnant Women): Healthy pregnant women 18-40 yrs of age (between 28-35 weeks gestation) Exclusion Criteria: - Group 1 (Non Pregnant Women): Pregnant or nursing; History of severe allergy to previous vaccines; Known HIV positive - Group 2 (Healthy Pregnant Women): History of severe allergy to previous vaccines; Known HIV positive |
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
South Africa | Chris Hani Baragwanath Hospital | Chris Hani Rd, Soweto | Johannesburg |
Lead Sponsor | Collaborator |
---|---|
Novartis Vaccines |
South Africa,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | Day 61, one month after the second vaccination | No |
Primary | 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 . | Day 61, one month after the second vaccination | No |
Primary | 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. | Day of delivery | No |
Primary | 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. | Day of delivery | No |
Secondary | 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. | Day 31, one month after vaccination | No |
Secondary | 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. | day 31 | No |
Secondary | 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. | Day 361, one year after the first vaccination | No |
Secondary | 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. | Day 361, one year after the first vaccination | No |
Secondary | 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. | Day 61 | Yes |
Secondary | 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. | From day 1 to one year after delivery | Yes |
Secondary | 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. | Day 4, day 43 and day 91 after birth | No |
Secondary | 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 | one year after birth | Yes |
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