A Study to Evaluate Safety and Immune Response of Novartis Meningococcal ACWY Conjugate Vaccine In Adolescents

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier:
NCT00518180
First received: August 17, 2007
Last updated: January 14, 2013
Last verified: January 2013
Results First Received: March 19, 2010  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Conditions: Meningococcal Meningitis
Human Papillomavirus Infection
Pertussis
Tetanus
Interventions: Biological: Novartis Meningococcal ACWY Conjugate Vaccine
Biological: Tdap Vaccine

  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 enrolled at a single center in Costa Rica.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
All enrolled subjects were randomized at a 1:1:1 ratio to receive the MenACWY vaccine when given alone and concomitantly with the Tdap vaccine and the HPV vaccine at different schedules.

Reporting Groups
  Description
MenACWY+Tdap+HPV The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
MenACWY→Tdap→HPV The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
Tdap →MenACWY → HPV Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.

Participant Flow:   Overall Study
    MenACWY+Tdap+HPV     MenACWY→Tdap→HPV     Tdap →MenACWY → HPV  
STARTED     540     541     539  
COMPLETED     475     472     457  
NOT COMPLETED     65     69     82  
Withdrawal by Subject                 29                 30                 42  
Lost to Follow-up                 30                 28                 34  
Administrative reason                 0                 2                 2  
Protocol Violation                 5                 7                 4  
Unable to classify                 0                 2                 0  
Adverse Event                 1                 0                 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.
No text entered.

Reporting Groups
  Description
MenACWY+Tdap+HPV The MenACWY vaccine was administered concomitantly with the Tdap vaccine and the HPV vaccine at study month 0 followed by two injections of the HPV vaccine at months 2 and 6.
MenACWY→Tdap→HPV The MenACWY vaccine was administered at study month 0 followed by one injection of the Tdap vaccine at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
Tdap →MenACWY → HPV Tdap vaccine was administered at month 0 followed by one injection of MenACWY at month 1, followed by three injections of the HPV vaccine at months 2, 4, and 8.
Total Total of all reporting groups

Baseline Measures
    MenACWY+Tdap+HPV     MenACWY→Tdap→HPV     Tdap →MenACWY → HPV     Total  
Number of Participants  
[units: participants]
  540     541     539     1620  
Age  
[units: years]
Mean ± Standard Deviation
  13.9  ± 2.1     13.9  ± 2.2     13.8  ± 2.2     13.9  ± 2.1  
Gender  
[units: participants]
       
Female     308     309     307     924  
Male     232     232     232     696  
Race/Ethnicity, Customized  
[units: participants]
       
Hispanic     539     541     539     1619  
Black     1     0     0     1  



  Outcome Measures
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1.  Primary:   Percentage of Subjects With hSBA Seroresponse   [ Time Frame: 1 month postvaccination ]

2.  Primary:   Percentage of Subjects With Antidiphtheria and Antitetanus Toxin ≥1.0 IU/mL   [ Time Frame: 1 month postvaccination ]

3.  Primary:   Geometric Mean Concentrations of Antipertussis Toxin [Anti-PT], Antifilamentous Hemagglutinin [Anti-FHA], and Antipertactin [Anti-PRN]   [ Time Frame: 1 month postvaccination ]

4.  Secondary:   Effect of Concomitant and Sequential Vaccination on hSBA GMTs for A, C, W, and Y Serogroups   [ Time Frame: 1 month postvaccination ]

5.  Secondary:   Percentage of Subjects With Anti-HPV Seroconversion   [ Time Frame: 1 month after third HPV vaccination ]

6.  Secondary:   Geometric Mean Titers (GMTs) of Anti-HPV by Competitive Luminex Immunoassay   [ Time Frame: 1 month after third HPV vaccination ]

7.  Secondary:   Percentage of Subjects With hSBA ≥ 1:8 for A, C, W, and Y Serogroups   [ Time Frame: 1 month postvaccination ]

8.  Secondary:   The Effect of Sequential Vaccination on Immunogenicity for Diphtheria and Tetanus   [ Time Frame: 1 month postvaccination ]

9.  Secondary:   Geometric Mean Concentrations for Diphtheria and Tetanus   [ Time Frame: 1 month postvaccination ]

10.  Secondary:   Geometric Mean Titers of Pertussis Antigens   [ Time Frame: 1 month postvaccination ]

11.  Secondary:   Percentage of Subjects With at Least a 4-fold Rise for PT, FHA, and PRN   [ Time Frame: 1 month postvaccination ]

12.  Secondary:   Number of Subjects With at Least One Reactogenicity Sign After MenACWY and Tdap Vaccination.   [ Time Frame: Days 1 to 7 ]

13.  Secondary:   Number of Subjects With at Least One Reactogenicity Sign After Each HPV Vaccination   [ Time Frame: Days 1 to 7 ]


  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 NOT 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.


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


Publications of Results:

Responsible Party: Novartis ( Novartis Vaccines )
ClinicalTrials.gov Identifier: NCT00518180     History of Changes
Other Study ID Numbers: V59P18
Study First Received: August 17, 2007
Results First Received: March 19, 2010
Last Updated: January 14, 2013
Health Authority: United States: Food and Drug Administration
Costa Rica: Ministry of Health Costa Rica