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Immune Response Induced by a Vaccine Against Group B Streptococcus and Safety in Pregnant Women and Their Offsprings

This study has been completed.
Sponsor:
Collaborator:
Novartis Vaccines
Information provided by (Responsible Party):
Novartis
ClinicalTrials.gov Identifier:
NCT01446289
First received: September 27, 2011
Last updated: September 5, 2014
Last verified: September 2014
Results First Received: June 20, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Prevention
Conditions: Streptococcal Infection
Gram-positive Bacterial Infection
Bacterial Infection
Interventions: Biological: Group B Streptococcus Trivalent Vaccine
Biological: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Participants were recruited from 5 centres.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
A total of 86 pregnant subjects were enrolled in the study. 86 infants were enrolled in this study, delivered by 86 maternal subjects. There were 86 singleton deliveries.

Reporting Groups
  Description
Mothers GBS Pregnant women who received one injection of GBS vaccine.
Mothers Placebo Pregnant women who received one injection of saline solution.
Infants GBS Infants born from mothers who received one injection of GBS vaccine.
Infants Placebo Infants born from mothers who received one injection of saline solution.

Participant Flow:   Overall Study
    Mothers GBS   Mothers Placebo   Infants GBS   Infants Placebo
STARTED   51   35   51   35 
COMPLETED   50   35   50   35 
NOT COMPLETED   1   0   1   0 
Withdrawal by Subject                1                0                1                0 



  Baseline Characteristics
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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.
All enrolled population

Reporting Groups
  Description
Mothers GBS Pregnant women who received one injection of GBS vaccine.
Mothers Placebo Pregnant women who received one injection of saline solution.
Infants GBS Infants born from mothers who received one injection of GBS vaccine.
Infants Placebo Infants born from mothers who received one injection of saline solution.
Total Total of all reporting groups

Baseline Measures
   Mothers GBS   Mothers Placebo   Infants GBS   Infants Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 51   35   51   35   172 
Age [1] [2] 
[Units: Years]
Mean (Standard Deviation)
 29.7  (4.9)   30  (5.5)   NA [2]   NA [2]   29.8  (5.1) 
[1] Analysis was done on the enrolled population.
[2] presented elsewhere
Age [1] [2] 
[Units: Days]
Mean (Standard Deviation)
 NA [2]   NA [2]   0  (0)   0  (0)   0  (0) 
[1] Analysis was done on the enrolled population.
[2] presented elsewhere
Gender [1] 
[Units: Participants]
         
Female   51   35   21   15   122 
Male   0   0   30   20   50 
[1] Analysis was done on the enrolled population.
Region of Enrollment 
[Units: Participants]
         
Canada   15   11   15   11   52 
Belgium   36   24   36   24   120 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Geometric Mean Concentrations (GMCs) of Antibodies in Mothers and Infants at Delivery/Birth   [ Time Frame: Day of delivery/birth ]

2.  Primary:   Geometric Mean of the Ratios Between Infant Antibody Level (μg/mL) and Maternal Antibody Level (μg/mL) at Time of Delivery   [ Time Frame: Day of delivery/birth ]

3.  Secondary:   GMCs (Enzyme-linked Immunosorbent Assay, ELISA) Antibodies Against Serotypes Ia, Ib and III in Maternal Subjects   [ Time Frame: Day 1, day 31 and day 91 post-delivery ]

4.  Secondary:   Geometric Mean Ratios (GMRs) of Antibody GMCs (ELISA) in Maternal Subjects   [ Time Frame: Day 31, day of delivery, day 91 post-delivery ]

5.  Secondary:   GMC (ELISA) of Anti-GBS CPS Antibodies in Infants   [ Time Frame: Day of birth and day 91 after birth ]

6.  Secondary:   GMRs of Anti-GBS CPS Antibody GMCs (ELISA) in Infants at 3 Months of Age Versus GMCs at Birth   [ Time Frame: Day 91 after birth ]

7.  Secondary:   Percentages of Infant Subjects Showing Anti-diphtheria Antibodies GMCs (ELISA) Over 0.1 IU/mL at 1 Month After the Last Routine Infant Immunization   [ Time Frame: 1 month after the last routine infant immunization ]

8.  Secondary:   Percentage of Maternal Subjects Reporting Solicited Local and Systemic Adverse Events (AEs)   [ Time Frame: From day 1 to 7 after vaccination ]

9.  Secondary:   Percentage of Maternal Subjects Reporting Unsolicited AEs and Serious Adverse Events (SAEs)   [ Time Frame: All AEs were recorded until delivery, after delivery all AEs requiring a non-routine physician’s visit and AEs leading to withdrawal from the study. SAEs were collected for the duration of the trial. ]

10.  Secondary:   Percentages of Infants Reporting SAEs   [ Time Frame: From birth until study termination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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
e-mail: RegistryContactVaccinesUS@novartis.com


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01446289     History of Changes
Other Study ID Numbers: V98_04
2010-020840-36
Study First Received: September 27, 2011
Results First Received: June 20, 2014
Last Updated: September 5, 2014