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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: December 18, 2012
Last verified: December 2012
History of Changes

September 1, 2010
December 18, 2012
September 2010
December 2011   (final data collection date for primary outcome measure)
  • 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
  • 2. Evaluation of Ab responses (ELISA) induced by different vaccine doses in pregnant women to select one dose for subsequent use [ Time Frame: Dose selection based on evaluation of data collected until delivery ] [ Designated as safety issue: No ]
    Tolerability data will be collected in this study
Same as current
Complete list of historical versions of study NCT01193920 on ClinicalTrials.gov Archive Site
  • 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
  • Evaluation of the immune-response to routine anti-diphtheria and anti-pneumococcal vaccinations among infants born to vaccine and placebo injected pregnant women [ Time Frame: at 18 weeks and 10 months of age ] [ Designated as safety issue: Yes ]
  • 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, 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 30-34 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
December 2012

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