We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01193920
Recruitment Status : Completed
First Posted : September 2, 2010
Results First Posted : May 5, 2014
Last Update Posted : August 22, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Streptococcal Infections Biological: Group B Streptococcus Trivalent Vaccine - 20/20/20 μg Other: Saline solution Biological: Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg Biological: Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg Biological: Group B Streptococcus Trivalent Vaccine - 5/5/5 μg Other: saline solution Phase 1 Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 380 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Study Start Date : October 2010
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 1: GBS Trivalent Vaccine with aluminium - 20/20/20 μg
Non-pregnant women who received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.
 Biological: Group B Streptococcus Trivalent Vaccine - 20/20/20 μg
Subjects received two injections of 20/20/20 μg dose of Group B Streptococcus (GBS) Trivalent Vaccine with aluminum.
Placebo Comparator: 2: Placebo - Sterile saline
Non-Pregnant Women who received two injection of saline solution.
 Other: Saline solution
Subjects received two injection of saline solution.
Experimental: 3: GBS Trivalent Vaccine - 0.5/0.5/0.5 µg
Pregnant women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
 Biological: Group B Streptococcus Trivalent Vaccine - 0.5/0.5/0.5 μg
Subjects received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
Experimental: 4: GBS Trivalent Vaccine - 2.5/2.5/2.5 µg
Pregnant Women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
 Biological: Group B Streptococcus Trivalent Vaccine - 2.5/2.5/2.5 μg
Subjects received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
Experimental: 5: GBS Trivalent Vaccine - 5/5/5 µg
Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
 Biological: Group B Streptococcus Trivalent Vaccine - 5/5/5 μg
Subjects received one injection of 5/5/5 μg dose of non adjuvanted Group B Streptococcus (GBS) Trivalent Vaccine.
Placebo Comparator: 6: Placebo - Sterile saline
Pregnant Women who received one injection of saline solution.
 Other: saline solution
Subjects received one injection of saline solution.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. The Percentages of Non-pregnant 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 ]
    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.

  2. Antibody Geometric Mean Concentrations (GMC) in Non-pregnant Women at One Month After the Second Vaccination. [ Time Frame: Day 61, 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 .

  3. The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery. [ Time Frame: 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.

  4. Antibody GMC in Maternal Subjects at Day of Delivery [ Time Frame: 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.


Secondary Outcome Measures :
  1. The Percentages of Maternal Subjects With Antibody Concentrations Above a Defined Threshold Per Serotype at One Month After Vaccination. [ Time Frame: Day 31, 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.

  2. Antibody GMC Per Serotype in Maternal Subjects at One Month After Vaccination [ Time Frame: day 31 ]
    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.

  3. The Percentage of Non-pregnant Subjects With Antibody Concentrations Above a Defined Threshold at One Year After the First Vaccination. [ Time Frame: Day 361, 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.

  4. Antibody GMC in Non-pregnant Subjects at One Year After the First Vaccination [ Time Frame: Day 361, 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.

  5. Number of Non-pregnant Subjects Reporting Solicited and Unsolicited Adverse Events [ Time Frame: Day 61 ]
    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.

  6. Number of Maternal Subjects Reporting Solicited and Unsolicited Adverse Events [ Time Frame: From day 1 to one year after delivery ]
    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.

  7. Antibody GMC Per Serotype at Different Time Points in Infants [ Time Frame: Day 4, day 43 and day 91 after birth ]
    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.

  8. Number of Infants Reporting Serious Adverse Events [ Time Frame: one year after birth ]
    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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01193920


Locations
Layout table for location information
South Africa
Chris Hani Baragwanath Hospital
Chris Hani Rd, Soweto, Johannesburg, South Africa
Sponsors and Collaborators
Novartis Vaccines
Investigators
Layout table for investigator information
Study Chair: Novartis Vaccines and Diagnostics Novartis
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: Novartis Vaccines
ClinicalTrials.gov Identifier: NCT01193920    
Other Study ID Numbers: V98_08
MCC Reference n° 20100601 ( Other Identifier: South African authorities )
First Posted: September 2, 2010    Key Record Dates
Results First Posted: May 5, 2014
Last Update Posted: August 22, 2014
Last Verified: August 2014
Keywords provided by Novartis ( Novartis Vaccines ):
Group B streptococcus
GBS
Vaccine
Prevention of group B streptococcus infection
Additional relevant MeSH terms:
Layout table for MeSH terms
Streptococcal Infections
Infections
Gram-Positive Bacterial Infections
Bacterial Infections
Bacterial Infections and Mycoses
 Pharmaceutical Solutions
Vaccines
Immunologic Factors
Physiological Effects of Drugs