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Primary Study to Demonstrate Non-inferiority and Immunogenicity of GSK Biologicals' Meningococcal Vaccine 134612

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00465816
First received: April 24, 2007
Last updated: November 21, 2012
Last verified: November 2012
History of Changes
Results First Received: April 23, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Prevention
Condition: Meningococcal Serogroup A, C, W-135, Y Diseases
Interventions: Biological: Nimenrix (Meningococcal vaccine 134612)
Biological: Twinrix

  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
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Nimenrix + Twinrix Group Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
Nimenrix Group Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
Twinrix Group Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.

Participant Flow:   Overall Study
    Nimenrix + Twinrix Group     Nimenrix Group     Twinrix Group  
STARTED     367     122     122  
COMPLETED     367     122     120  
NOT COMPLETED     0     0     2  
Lost to Follow-up                 0                 0                 2  



  Baseline Characteristics
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Reporting Groups
  Description
Nimenrix + Twinrix Group Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
Nimenrix Group Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
Twinrix Group Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
Total Total of all reporting groups

Baseline Measures
    Nimenrix + Twinrix Group     Nimenrix Group     Twinrix Group     Total  
Number of Participants  
[units: participants]
 		  367     122     122     611  
Age  
[units: Years]
Mean ± Standard Deviation 		  14.3  ± 1.89     14.3  ± 1.84     14.3  ± 1.94     14.3  ± 1.89  
Gender  
[units: Subjects]
 		       
Female     195     61     68     324  
Male     172     61     54     287  



  Outcome Measures
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1.  Primary:   Meningococcal Polysaccharide A Serum Bactericidal Antibodies/Assay, Using Baby Rabbit Complement for Assay (rSBA-MenA), rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers   [ Time Frame: At 1 month after vaccination with Nimenrix vaccine (Month 1) ]
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2.  Primary:   Number of Subjects Seroconverted for Hepatitis A   [ Time Frame: At 1 month after the third dose of Twinrix vaccine (Month 7) ]
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3.  Primary:   Number of Subjects Seroprotected for Hepatitis B   [ Time Frame: At 1 month after the third dose of Twinrix vaccine (Month 7) ]
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4.  Secondary:   Number of Subjects With a Vaccine Response to MenA, MenC, MenY and MenW-135   [ Time Frame: At 1 month after vaccination with Nimenrix vaccine (Month 1) ]
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5.  Secondary:   Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values   [ Time Frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) ]
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6.  Secondary:   Anti-PSA (Polysaccharide A), Anti-PSC (Polysaccharide C), Anti-PSW-135 (Polysaccharide W-135), and Anti-PSY (Polysaccharide Y) Antibody Concentrations   [ Time Frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) ]
  Show Outcome Measure 6

7.  Secondary:   Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135, and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values   [ Time Frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) ]
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8.  Secondary:   Anti-Tetanus Toxoid (TT) Antibody Concentrations   [ Time Frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) ]
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9.  Secondary:   Number of Subjects With Anti-tetanus Toxoid Antibody Concentrations Above the Pre-defines Cut-off Value   [ Time Frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) ]
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10.  Secondary:   rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7   [ Time Frame: At Month 7 ]
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11.  Secondary:   Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers Above Predefined Cut-off Values at Month 7   [ Time Frame: At Month 7 ]
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12.  Secondary:   Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7   [ Time Frame: At Month 7 ]
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13.  Secondary:   Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations Above Pre-defined Cut-off Values at Month 7   [ Time Frame: At Month 7 ]
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14.  Secondary:   Immunoglobulin G (IgG) Anti-HAV Antibody Concentrations   [ Time Frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7) ]
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15.  Secondary:   Number of Subjects With IgG Anti-HAV Antibody Concentrations Above the Pre-defined Cut-off Value   [ Time Frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7) ]
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16.  Secondary:   IgG Anti-HBs Antibody Concentrations   [ Time Frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7) ]
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17.  Secondary:   Number of Subjects With IgG Anti-HB Antibody Concentrations Above the Pre-defined Cut-off Value   [ Time Frame: Prior to the first dose (Month 0) and 1 month after the third dose of Twinrix vaccine (Month 7) ]
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18.  Secondary:   Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination   [ Time Frame: During a 4-day period after Nimenrix vaccination ]
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19.  Secondary:   Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination   [ Time Frame: During a 4-day period after each Twinrix vaccination ]
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20.  Secondary:   Number of Subjects Reporting Any Solicited General Symptoms   [ Time Frame: During a 4-day period after any vaccination ]
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21.  Secondary:   Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)   [ Time Frame: Up to 1 month after each vaccine dose ]
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22.  Secondary:   Number of Subjects Reporting Any Specific AEs of New Onset of Chronic Illnesses   [ Time Frame: During the entire study (up to Month 7) ]
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23.  Secondary:   Number of Subjects Reporting Any Rash   [ Time Frame: During the entire study (up to Month 7) ]
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24.  Secondary:   Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits   [ Time Frame: During the entire study (up to Month 7) ]
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25.  Secondary:   Number of Subjects Reporting Any Serious Adverse Events (SAEs)   [ Time Frame: During the entire study (up to Month 7) ]
  Show Outcome Measure 25


  Serious Adverse Events
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Time Frame Serious Adverse Events were reported throughout the entire study period (up to Month 7). Other Frequent (non-serious) Adverse Events were reported during a 4-day follow-up period after any vaccine dose.
Additional Description Other Frequent (non-serious) Adverse Events were reported only for those subjects who received the vaccination and completed their symptom sheet.

Reporting Groups
  Description
Nimenrix + Twinrix Group Subjects received 1 dose of Nimenrix™ vaccine at Month 0 and 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.
Nimenrix Group Subjects received 1 dose of Nimenrix™ vaccine at Month 0.
Twinrix Group Subjects received 1 dose of Twinrix™ vaccine at Months 0, 1 and 6.

Serious Adverse Events
    Nimenrix + Twinrix Group     Nimenrix Group     Twinrix Group  
Total, serious adverse events        
# participants affected / at risk     4/367 (1.09%)     0/122 (0.00%)     1/122 (0.82%)  
Injury, poisoning and procedural complications        
Brain contusion *      
# participants affected / at risk     0/367 (0.00%)     0/122 (0.00%)     1/122 (0.82%)  
Concussion *      
# participants affected / at risk     1/367 (0.27%)     0/122 (0.00%)     0/122 (0.00%)  
Drug toxicity *      
# participants affected / at risk     1/367 (0.27%)     0/122 (0.00%)     0/122 (0.00%)  
Nervous system disorders        
Hydrocephalus *      
# participants affected / at risk     1/367 (0.27%)     0/122 (0.00%)     0/122 (0.00%)  
Syncope *      
# participants affected / at risk     1/367 (0.27%)     0/122 (0.00%)     0/122 (0.00%)  
Psychiatric disorders        
Depression *      
# participants affected / at risk     1/367 (0.27%)     0/122 (0.00%)     0/122 (0.00%)  
* Events were collected by non-systematic assessment




  Other Adverse Events
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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.


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
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Results Point of Contact:  
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
phone: 866-435-7343


Publications:
Ostergaard L et al. (2012) A tetravalent meningococcal serogroups A, C, W-135, and Y tetanus toxoid conjugate vaccine is immunogenic and well-tolerated when co-administered with Twinrix(®) in subjects aged 11-17 years: an open, randomised, controlled trial. Vaccine. 30(4):774-83.

Publications automatically indexed to this study:


Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00465816     History of Changes
Other Study ID Numbers: 109063
Study First Received: April 24, 2007
Results First Received: April 23, 2012
Last Updated: November 21, 2012
Health Authority: Sweden: Medical Products Agency