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Safety and Dose Ranging Study of Acellular Pertussis and Acellular Pertussis -Tetanus-Diphtheria Booster Vaccines in Healthy Adults Ages 18 to 40 Years

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ClinicalTrials.gov Identifier: NCT01529645
Recruitment Status : Completed
First Posted : February 9, 2012
Results First Posted : September 18, 2014
Last Update Posted : April 4, 2016
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Prevention
Conditions: Pertussis
Whooping Cough
Tetanus
Lockjaw
Diphtheria
Interventions: Biological: Acellular pertussis vaccine
Biological: Tetanus, reduced diphtheria, and acellular pertussis vaccine (adsorbed)
Biological: Licensed TdaP booster vaccine
Biological: Diphtheria and tetanus vaccine (adsorbed, reduced antigen content, Germany)
Other: Saline solution

  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
Group aP1 Subjects received a single dose of aP booster vaccine (containing a low dose of PT, FHA and PRN antigens) on day 1 of this study.
Group aP2 Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
Group aP4 Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this 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 day 1 of this 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 day 1 of this 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 day 1 of this 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 day 1 of this 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 day 1 of this 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 day 1 of this 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 day 1 of this 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   42   42   42   42   42   42   42   42   42   42 
COMPLETED   40   41   40   40   40   41   40   42   41   42 
NOT COMPLETED   2   1   2   2   2   1   2   0   1   0 
Lost to Follow-up                0                1                1                1                1                0                2                0                1                0 
SAE - Premature contractions                0                0                1                0                0                0                0                0                0                0 
Withdrawal by Subject                2                0                0                1                1                1                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.
Analysis was done on the all enrolled set, ie, all subjects who have signed an informed consent, undergone screening procedures and were randomized.

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 day 1 of this study.
Group aP2 Subjects received a single dose of aP booster vaccine (containing a medium dose of PT, FHA and PRN antigens) on day 1 of this study.
Group aP4 Subjects received a single dose of aP booster vaccine (containing a high dose of PT, FHA and PRN antigens) on day 1 of this 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 and a fixed dose of tetanus toxoid) on day 1 of this 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 day 1 of this 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 day 1 of this 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 day 1 of this 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 day 1 of this 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 day 1 of this 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 day 1 of this 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]
 42   42   42   42   42   42   42   42   42   42   420 
Age 
[Units: Years]
Mean (Standard Deviation)
 26.6  (5.6)   26.8  (5.1)   27.4  (6.5)   26.8  (5.7)   27.7  (5.9)   25.8  (5.2)   25.1  (4.2)   27.5  (5.1)   27.2  (5.6)   27.4  (6.4)   26.8  (5.5) 
Gender 
[Units: Participants]
                     
Female   24   28   25   23   27   24   29   19   27   24   250 
Male   18   14   17   19   15   18   13   23   15   18   170 


  Outcome Measures

1.  Primary:   The Number of Subjects Reporting Solicited Local and Systemic Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine   [ Time Frame: Day 1 through 7 after vaccination ]

2.  Primary:   The Number of Subjects Reporting Unsolicited Adverse Events After Receiving Different Formulations of aP and TdaP Booster Vaccine   [ Time Frame: From day 1 to day 365 ]

3.  Primary:   Geometric Mean Concentrations (GMCs) of Antibodies in aP1, aP2, aP4 Groups Against Pertussis Antigens Following Booster Vaccination   [ Time Frame: Day 1 (baseline) and Day 30 post vaccination ]

4.  Primary:   GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Groups Against Pertussis Antigens Following Booster Vaccination   [ Time Frame: Day 1 (baseline) and Day 30 post vaccination ]

5.  Primary:   GMCs of Antibodies in T5D4aP1, T5D4aP2 and T5D4aP4 Groups Against Pertussis Antigens Following Vaccination   [ Time Frame: Day 1 (baseline) and Day 30 post vaccination ]

6.  Primary:   Geometric Mean Ratios (GMRs) of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in aP1, aP2, aP4 Booster Groups Against Pertussis Antigens   [ Time Frame: Day 30 post vaccination/baseline (Day 1) ]

7.  Primary:   GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies in T5D2aP1, T5D2aP2 and T5D2aP4 Booster Groups Against Pertussis Antigens   [ Time Frame: Day 30 post vaccination/baseline (Day 1) ]

8.  Primary:   GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies for T5D4aP1, T5D4aP2 and T5D4aP4 Booster Groups Against Pertussis Antigens   [ Time Frame: Day 30 post vaccination/baseline (Day 1) ]

9.  Primary:   Percentages of Subjects With Diphtheria and Tetanus Antitoxin Units >= 0.1/mL After Vaccination   [ Time Frame: Day 1 (baseline) and Day 30 post vaccination ]

10.  Secondary:   Percentages of Subjects With 2- and 4-fold Increase in GMCs Against Pertussis Antigens Following Vaccination.   [ Time Frame: Day 30 post vaccination ]

11.  Secondary:   GMCs of Antibodies Against Diphtheria and Tetanus Antigens Following Vaccination   [ Time Frame: Day 1 (baseline) and Day 30 post vaccination ]

12.  Secondary:   GMRs of Post Vaccination Versus Pre Vaccination GMCs of Antibodies Against Diphtheria and Tetanus Antigens   [ Time Frame: Day 30 post vaccination/Day 1 ]


  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 Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.


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



Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT01529645     History of Changes
Other Study ID Numbers: V113_01
2011-000688-28 ( EudraCT Number )
First Submitted: February 6, 2012
First Posted: February 9, 2012
Results First Submitted: April 30, 2014
Results First Posted: September 18, 2014
Last Update Posted: April 4, 2016