ClinicalTrials.gov
ClinicalTrials.gov Menu

Persistency Study After aP / Tdap Booster Vaccines in Adult Subjects (V113_01 Extension 1)

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: NCT02382913
Recruitment Status : Completed
First Posted : March 9, 2015
Results First Posted : February 12, 2016
Last Update Posted : March 24, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label)
Condition: Pertussis
Interventions: Biological: aP booster
Biological: TdaP booster
Biological: Licensed TdaP booster (Boostrix®)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations

Subjects were enrolled at one site in Belgium.

- V113_01 parent study number: NCT01529645


Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled subjects were included in the trial.

Reporting Groups
  Description
Group aP1 Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
Group aP2 Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
Group aP4 Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
Group T5D2aP1 Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
Group T5D2aP2 Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
Group T5D2aP4 Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
Group T5D4aP1 Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
Group T5D4aP2 Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
Group T5D4aP4 Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
Licensed Tdap Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.

Participant Flow:   Overall Study
    Group aP1   Group aP2   Group aP4   Group T5D2aP1   Group T5D2aP2   Group T5D2aP4   Group T5D4aP1   Group T5D4aP2   Group T5D4aP4   Licensed Tdap
STARTED   27   36   32   27   33   30   37   30   30   33 
COMPLETED   27   36   32   27   33   30   37   30   30   33 
NOT COMPLETED   0   0   0   0   0   0   0   0   0   0 



  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
Group aP1 Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
Group aP2 Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
Group aP4 Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
Group T5D2aP1 Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
Group T5D2aP2 Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
Group T5D2aP4 Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a low dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
Group T5D4aP1 Subjects received a single dose of TdaP booster vaccine (containing a low dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
Group T5D4aP2 Subjects received a single dose of TdaP booster vaccine (containing a medium dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
Group T5D4aP4 Subjects received a single dose of TdaP booster vaccine (containing a high dose of PT, FHA, PRN antigens, a double dose of diphtheria toxoid and a fixed dose of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
Licensed Tdap Subjects received a single dose of a comparator TdaP booster vaccine (containing 8 μg each of PT, FHA and 2.5 μg of PRN antigens and 2.5 Lf of diphtheria toxoid and 5 Lf of tetanus toxoid) on parent study V113_01 and had blood collected at approximately 3 years later, in current V113_01E1 study.
Total Total of all reporting groups

Baseline Measures
   Group aP1   Group aP2   Group aP4   Group T5D2aP1   Group T5D2aP2   Group T5D2aP4   Group T5D4aP1   Group T5D4aP2   Group T5D4aP4   Licensed Tdap   Total 
Overall Participants Analyzed 
[Units: Participants]
 27   36   32   27   33   30   37   30   30   33   315 
Age 
[Units: Years]
Mean (Standard Deviation)
 30.2  (5.7)   29.5  (4.9)   30.3  (6.4)   31.3  (6.3)   30.9  (5.7)   30  (5.6)   28.2  (4.4)   30.1  (4.6)   31.3  (5.9)   31.5  (6.7)   30.3  (5.6) 
Gender 
[Units: Participants]
                     
Female   17   25   19   11   19   16   27   13   19   21   187 
Male   10   11   13   16   14   14   10   17   11   12   128 


  Outcome Measures

1.  Primary:   Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens at Day 1.   [ Time Frame: Day 1 ]

2.  Primary:   Geometric Mean Concentrations (GMCs) of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens at Day 1.   [ Time Frame: Day 1 ]

3.  Primary:   Geometric Mean Concentrations (GMCs) of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens at Day 1.   [ Time Frame: Day 1 ]

4.  Primary:   Geometric Mean Ratios Antibodies Concentrations in aP1, aP2, aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.   [ Time Frame: Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1 ]

5.  Primary:   Geometric Mean Ratios Antibodies Concentrations in T5D2aP1, T5D2aP2 and T5D2aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.   [ Time Frame: Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1 ]

6.  Primary:   Geometric Mean Ratios Antibodies Concentrations in T5D4aP1, T5D4aP2 and T5D4aP4 Groups as Measured at V113_01E1 Day 1 vs. All V113_01 Time Points.   [ Time Frame: Day 1, Day 8, Day 30, Day 180, Day 365 of V113_01 and Day 1 of V113_01E1 ]


  Serious Adverse Events


  Other Adverse Events


  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

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



Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT02382913     History of Changes
Other Study ID Numbers: V113_01E1
2014-003729-16 ( EudraCT Number )
First Submitted: February 27, 2015
First Posted: March 9, 2015
Results First Submitted: January 14, 2016
Results First Posted: February 12, 2016
Last Update Posted: March 24, 2016