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Immunogenicity and Safety of the Concomitant Administration of a Tdap Vaccine and Meningococcal ACWY Conjugate Vaccine in Healthy Subjects Aged 11-25 Years

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ClinicalTrials.gov Identifier: NCT00329901
Recruitment Status : Completed
First Posted : May 25, 2006
Results First Posted : June 18, 2014
Last Update Posted : June 18, 2014
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Prevention
Conditions: Meningococcal Disease
Meningococcal Meningitis
Interventions: Biological: Meningococcal ACWY conjugate vaccine (MenACWY-CRM)
Biological: Combined tetanus, reduced diphtheria and acellular pertussis vaccine (Tdap)
Biological: saline placebo

  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 recruited from 14 centers in Italy.

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

Reporting Groups
  Description
Tdap + MenACWY-CRM Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
Tdap + Saline Subjects received Tdap vaccine and saline (placebo)concomitantly, in separate arms
MenACWY-CRM + Saline Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms

Participant Flow:   Overall Study
    Tdap + MenACWY-CRM   Tdap + Saline   MenACWY-CRM + Saline
STARTED   361   354   357 
COMPLETED   352   349   353 
NOT COMPLETED   9   5   4 
Withdrawal by Subject                4                3                2 
Lost to Follow-up                2                0                1 
Protocol Violation                1                0                1 
Unable to classify                2                2                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.
Baseline Characteristics are summarized for all enrolled population

Reporting Groups
  Description
Tdap + MenACWY-CRM Subjects received Tdap vaccine and MenACWY-CRM vaccine concomitantly, in separate arms
Tdap + Saline Subjects received Tdap vaccine and saline (placebo) concomitantly, in separate arms
MenACWY-CRM + Saline Subjects received MenACWY-CRM vaccine and saline (placebo) concomitantly, in separate arms
Total Total of all reporting groups

Baseline Measures
   Tdap + MenACWY-CRM   Tdap + Saline   MenACWY-CRM + Saline   Total 
Overall Participants Analyzed 
[Units: Participants]
 361   354   357   1072 
Age 
[Units: Years]
Mean (Standard Deviation)
 14.4  (3.4)   14.1  (3.2)   14.3  (3.2)   14.3  (3.3) 
Gender 
[Units: Participants]
       
Female   189   164   165   518 
Male   172   190   192   554 


  Outcome Measures

1.  Primary:   Percentage of Subjects With an Immune Response Against Diphtheria, Tetanus and Pertussis, When Tdap is Concomitantly Administered With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo   [ Time Frame: 1 month after vaccination (Day 29) ]

2.  Secondary:   Percentage of Subjects With Anti-diphtheria and Anti-tetanus Concentrations ≥ 0.1 IU/mL When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo   [ Time Frame: 1 month after vaccination (Day 29) ]

3.  Secondary:   Geometric Mean Concentrations (GMCs) of Antibodies Against Diphtheria,Tetanus and Pertussis Antigens After Concomitant Administration of Tdap With MenACWY-CRM Compared to Tdap Given Concomitantly With Saline Placebo   [ Time Frame: 1 month after vaccination (Day 29) ]

4.  Secondary:   Geometric Mean Ratios of Antibody Concentrations Against Diphtheria,Tetanus and Pertussis Antigens When Tdap is Administered Concomitantly With MenACWY-CRM Vaccine Compared to Tdap Given Concomitantly With Saline Placebo   [ Time Frame: 1 month after vaccination (Day 29) ]

5.  Secondary:   Percentage of Subjects With Serum Bactericidal Antibody Titers ≥1:4 and ≥1:8, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo   [ Time Frame: 1 month after vaccination (Day 29) ]

6.  Secondary:   The hSBA Geometric Mean Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Vaccine Compared to MenACWY-CRM Given Concomitantly With Saline Placebo   [ Time Frame: 1 month after vaccination (Day 29) ]

7.  Secondary:   Geometric Mean Ratios of hSBA Titers Against N.Meningitidis Serogroups A,C,W and Y, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo   [ Time Frame: 1 month after vaccination (Day 29) ]

8.  Secondary:   Percentage of Subjects With hSBA Seroresponse, When MenACWY-CRM is Concomitantly Administered With Tdap Compared to MenACWY-CRM Given Concomitantly With Saline Placebo   [ Time Frame: 1 month after vaccination (Day 29) ]

9.  Secondary:   Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When MenACWY-CRM is Concomitantly Administered With Saline Placebo   [ Time Frame: Day 1-7 after any vaccination ]

10.  Secondary:   Number of Subjects With Solicited Local and Systemic Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to When Tdap is Concomitantly Administered With Saline Placebo   [ Time Frame: Day 1-7 after any vaccination ]

11.  Secondary:   Number of Subjects With Unsolicited Adverse Events When Tdap is Concomitantly Administered With MenACWY-CRM Compared to MenACWY-CRM or Tdap Concomitantly Administered With Saline Placebo   [ Time Frame: Throughout the study (Day 1 to Day 181) ]


  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 and Diagnostics
e-mail: RegistryContactVaccinesUS@novartis.com


Publications of Results:

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00329901     History of Changes
Other Study ID Numbers: V59P11
2005-005519-12 ( EudraCT Number )
First Submitted: May 23, 2006
First Posted: May 25, 2006
Results First Submitted: August 27, 2013
Results First Posted: June 18, 2014
Last Update Posted: June 18, 2014