Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT01193920
First received: September 1, 2010
Last updated: April 3, 2014
Last verified: April 2014

September 1, 2010
April 3, 2014
October 2010
December 2011   (final data collection date for primary outcome measure)
  • The Percentages of Subjects With Antibody Concentrations Above a Defined Threshold at One Month After the Second Vaccination. [ Time Frame: Day 61, one month after the second vaccination ] [ Designated as safety issue: No ]
    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.
  • Geometric Mean Concentrations (GMC) of Antibodies at One Month After the Second Vaccination. [ Time Frame: Day 61, one month after the second vaccination ] [ Designated as safety issue: No ]
    Antibody Geometric Mean Concentrations (GMC) per serotype in non-pregnant women after receiving two doses of the study vaccine administered one month apart .
  • Number of Subjects Reporting Solicited and Unsolicited Adverse Events [ Time Frame: Day 61 ] [ Designated as safety issue: Yes ]
    Number of 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
  • The Percentages of Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. [ Time Frame: Day of delivery ] [ Designated as safety issue: No ]
    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.
  • Antibody Geometric Mean Concentrations (GMC) at Day of Delivery [ Time Frame: Day of delivery ] [ Designated as safety issue: No ]
    Antibody Geometric Mean Concentrations (GMC) per serotype at day of delivery following one administration of one of three different doses of the study vaccine or placebo.
  • 2. Evaluation of Ab responses (ELISA) induced by different vaccine doses in pregnant women to select one dose for subsequent use [ Time Frame: Responses will be analyzed up to 1 yr post last injection ] [ Designated as safety issue: Yes ]
    Tolerability data will be collected in this study
  • 1. Measurement of safety and tolerability in non-pregnant and pregnant women and infants by analysis of local reactogenicity, AEs and SAEs [ Time Frame: Responses will be analyzed up to 1 yr post last injection ] [ Designated as safety issue: Yes ]
    Tolerability data will be collected in this study
Complete list of historical versions of study NCT01193920 on ClinicalTrials.gov Archive Site
  • The Percentages of Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. [ Time Frame: Day 31, one month after vaccination ] [ Designated as safety issue: No ]
    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.
  • Antibody GMC Per Serotype at One Month After Vaccination [ Time Frame: day 31 ] [ Designated as safety issue: No ]
    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.
  • The Percentage of Subjects With Antibody (Ab) Concentrations Above a Defined Threshold at One Year After the First Vaccination. [ Time Frame: Day 361, one year after the first vaccination ] [ Designated as safety issue: No ]
    The percentage of non-pregnant subjects with Ab 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
  • Geometric Mean Concentrations (GMC) of Antibodies at One Year After the First Vaccination [ Time Frame: Day 361, one year after the first vaccination ] [ Designated as safety issue: No ]
    Antibody Geometric Mean Concentrations (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.
  • Number of Subjects Reporting Solicited and Unsolicited Adverse Events [ Time Frame: From day 1 to one year after delivery ] [ Designated as safety issue: Yes ]
    Number of subjects reporting solicited and unsolicited adverse events following the administration of either one of three different doses of the study vaccine or placebo.
  • Antibody GMC Per Serotype at Different Time Points in Infants [ Time Frame: Day 4, day 43 and day 91 after birth ] [ Designated as safety issue: No ]
    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.
  • Number of Subjects Reporting Serious Adverse Events [ Time Frame: one year after birth ] [ Designated as safety issue: Yes ]
    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
  • Persistence of Ab induced by different vaccine doses will be evaluated over time (from screening to up to 1 yr post last injection) [ Time Frame: 1 month post last injection and 12 months post last injection ] [ Designated as safety issue: Yes ]
    Tolerability and safety will be assessed
  • Effect of vaccine on GBS colonization will be assessed at screening, delivery and 3 mo following delivery [ Time Frame: 1 month post last injection and 12 months post last injection ] [ Designated as safety issue: Yes ]
    Tolerability and safety will be assessed
  • Persistence of vaccine-induced Ab in infants will be measured at birth, at 6 weeks and 3 mo of age [ Time Frame: 1 month post last injection and 12 months post last injection ] [ Designated as safety issue: Yes ]
    Tolerability and safety will be assessed
Not Provided
Not Provided
 
Safety and Immunogenicity of a Group B Streptococcus Vaccine in Non Pregnant and Pregnant Women 18-40 Years of Age
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

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Streptococcal Infections
Biological: Group B streptococcus (GBS) vaccine
The vaccine will be studied (i) first in non-pregnant women and (ii) then in pregnant women. Two injections of a GBS at a specified dose, will be evaluated for safety and tolerability in the non-pregnant "lead in cohort" (Enrollment Group 1). Three different doses will then be evaluated in Enrollment Group 2 (pregnant women). This will allow for selection of a single dose for future development of a GBS vaccine for pregnant women.
  • Placebo Comparator: 1: Glycoconjugate (GC) Concentration - 20/20/20
    Enrollment Group 1: Non-Pregnant Women
    Intervention: Biological: Group B streptococcus (GBS) vaccine
  • Placebo Comparator: 2: Placebo - Sterile saline
    Enrollment Group 1: Non-Pregnant Women
    Intervention: Biological: Group B streptococcus (GBS) vaccine
  • Placebo Comparator: 3: GC Concentration - 0.5/0.5/0.5 µg
    Enrollment Group 2: Pregnant Women
    Intervention: Biological: Group B streptococcus (GBS) vaccine
  • Placebo Comparator: 4: GC Concentration - 2.5/2.5/2.5 µg
    Enrollment Group 2: Pregnant Women
    Intervention: Biological: Group B streptococcus (GBS) vaccine
  • Placebo Comparator: 5: GC Concentration - 5/5/5 µg
    Enrollment Group 2: Pregnant Women
    Intervention: Biological: Group B streptococcus (GBS) vaccine
  • Placebo Comparator: 6: Placebo - Sterile saline
    Enrollment Group 2: Pregnant Women
    Intervention: Biological: Group B streptococcus (GBS) vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
380
December 2012
December 2011   (final data collection date for primary outcome measure)

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
Female
18 Years to 40 Years
Yes
Contact information is only displayed when the study is recruiting subjects
South Africa
 
NCT01193920
V98_08, MCC Reference n° 20100601
Not Provided
Novartis ( Novartis Vaccines )
Novartis Vaccines
Not Provided
Study Chair: Novartis Vaccines and Diagnostics Novartis
Novartis
April 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP