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
Results First Received: December 17, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Condition: Streptococcal Infections
Intervention: Biological: Group B streptococcus (GBS) vaccine

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Non-pregnant 20/20/20 μg +Aluminum Hydroxide Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
Non-pregnant/Placebo Non-pregnant women received two injections of saline solution
Pregnant 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 trivalent GBS vaccine
Pregnant 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 trivalent GBS vaccine
Pregnant 5/5/5 μg Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
Pregnant/Placebo Pregnant women who received one injection of saline solution
Infants 0.5/0.5/0.5 μg Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
Infants 2.5/2.5/2.5 μg Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
Infants 5/5/5 μg Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
Infants / Placebo Infants born from women who received saline solution

Participant Flow:   Overall Study
    Non-pregnant 20/20/20 μg +Aluminum Hydroxide     Non-pregnant/Placebo     Pregnant 0.5/0.5/0.5 μg     Pregnant 2.5/2.5/2.5 μg     Pregnant 5/5/5 μg     Pregnant/Placebo     Infants 0.5/0.5/0.5 μg     Infants 2.5/2.5/2.5 μg     Infants 5/5/5 μg     Infants / Placebo  
STARTED     40     20     80     80     80     80     80     80     76     81  
COMPLETED     37     20     74     76     74     76     74     76     71     74  
NOT COMPLETED     3     0     6     4     6     4     6     4     5     7  
Withdrawal by Subject                 1                 0                 5                 1                 3                 1                 3                 0                 1                 0  
Lost to Follow-up                 1                 0                 1                 1                 3                 3                 1                 0                 2                 3  
Protocol Violation                 1                 0                 0                 0                 0                 0                 0                 0                 0                 0  
Death                 0                 0                 0                 1                 0                 0                 2                 3                 2                 4  
Unable to classify                 0                 0                 0                 1                 0                 0                 0                 1                 0                 0  



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Non-pregnant 20/20/20 μg +Aluminum Hydroxide Non-pregnant women who received two injections of 20/20/20 μg dose of trivalent GBS vaccine with aluminum
Non-pregnant/Placebo Non-pregnant women received two injections of saline solution
Pregnant 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 trivalent GBS vaccine
Pregnant 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 trivalent GBS vaccine
Pregnant 5/5/5 μg Pregnant women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
Pregnant/Placebo Pregnant women who received one injection of saline solution
Infants 0.5/0.5/0.5 μg Infants born from women who received one injection of 0.5/0.5/0.5 μg dose of non adjuvanted trivalent GBS vaccine
Infants 2.5/2.5/2.5 μg Infants born from women who received one injection of 2.5/2.5/2.5 μg dose of non adjuvanted trivalent GBS vaccine
Infants 5/5/5 μg Infants born from women who received one injection of 5/5/5 μg dose of non adjuvanted trivalent GBS vaccine
Infants / Placebo Infants born from women who received one injection of saline solution
Total Total of all reporting groups

Baseline Measures
    Non-pregnant 20/20/20 μg +Aluminum Hydroxide     Non-pregnant/Placebo     Pregnant 0.5/0.5/0.5 μg     Pregnant 2.5/2.5/2.5 μg     Pregnant 5/5/5 μg     Pregnant/Placebo     Infants 0.5/0.5/0.5 μg     Infants 2.5/2.5/2.5 μg     Infants 5/5/5 μg     Infants / Placebo     Total  
Number of Participants  
[units: participants]
  40     20     80     80     80     80     80     80     76     81     697  
Age, Customized  
[units: years]
Mean ± Standard Deviation
                     
Non pregnant subjects     28.6  ± 5.0     29.4  ± 5.1     NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   28.8  ± 5.0  
Maternal subjects     NA  ± NA [1]   NA  ± NA [1]   25.3  ± 5.2     25.3  ± 5.2     24.2  ± 4.7     25.7  ± 5.4     NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   25.1  ± 5.1  
Age, Customized  
[units: days]
Mean ± Standard Deviation
  NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   NA  ± NA [1]   3.0  ± 3.3     4.0  ± 7.8     5.5  ± 16.9     3.5  ± 8.8     4.0  ± 10.3  
Gender  
[units: participants]
                     
Female     40     20     80     80     80     80     45     38     33     48     544  
Male     0     0     0     0     0     0     35     42     43     33     153  
Region of Enrollment  
[units: participants]
                     
South Africa     40     20     80     80     80     80     80     80     76     81     697  
[1] presented elsewhere



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   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 ]

2.  Primary:   Geometric Mean Concentrations (GMC) of Antibodies at One Month After the Second Vaccination.   [ Time Frame: Day 61, one month after the second vaccination ]

3.  Primary:   Number of Subjects Reporting Solicited and Unsolicited Adverse Events   [ Time Frame: Day 61 ]

4.  Primary:   The Percentages of Subjects With Antibody Concentrations Above a Defined Threshold at Day of Delivery.   [ Time Frame: Day of delivery ]

5.  Primary:   Antibody Geometric Mean Concentrations (GMC) at Day of Delivery   [ Time Frame: Day of delivery ]

6.  Secondary:   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 ]

7.  Secondary:   Antibody GMC Per Serotype at One Month After Vaccination   [ Time Frame: day 31 ]

8.  Secondary:   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 ]

9.  Secondary:   Geometric Mean Concentrations (GMC) of Antibodies at One Year After the First Vaccination   [ Time Frame: Day 361, one year after the first vaccination ]

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

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

12.  Secondary:   Number of Subjects Reporting Serious Adverse Events   [ Time Frame: one year after birth ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Posting Director
Organization: Novartis Vaccines and Diagnostics
e-mail: RegistryContactVaccinesUS@novartis.com


No publications provided


Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01193920     History of Changes
Other Study ID Numbers: V98_08, MCC Reference n° 20100601
Study First Received: September 1, 2010
Results First Received: December 17, 2013
Last Updated: April 3, 2014
Health Authority: South Africa: Medicines Control Council (MCC)