Text Size

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
  Hide 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
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
  Hide Baseline Characteristics

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
  Show All Outcome Measures

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) ]
  Show Outcome Measure 1

2.  Primary:   Number of Subjects Seroconverted for Hepatitis A   [ Time Frame: At 1 month after the third dose of Twinrix vaccine (Month 7) ]
  Show Outcome Measure 2

3.  Primary:   Number of Subjects Seroprotected for Hepatitis B   [ Time Frame: At 1 month after the third dose of Twinrix vaccine (Month 7) ]
  Show Outcome Measure 3

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) ]
  Show Outcome Measure 4

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) ]
  Show Outcome Measure 5

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) ]
  Show Outcome Measure 7

8.  Secondary:   Anti-Tetanus Toxoid (TT) Antibody Concentrations   [ Time Frame: Prior to and 1 month after vaccination with Nimenrix vaccine (Months 0 and 1) ]
  Show Outcome Measure 8

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) ]
  Show Outcome Measure 9

10.  Secondary:   rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Titers at Month 7   [ Time Frame: At Month 7 ]
  Show Outcome Measure 10

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 ]
  Show Outcome Measure 11

12.  Secondary:   Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations at Month 7   [ Time Frame: At Month 7 ]
  Show Outcome Measure 12

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 ]
  Show Outcome Measure 13

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) ]
  Show Outcome Measure 14

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) ]
  Show Outcome Measure 15

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) ]
  Show Outcome Measure 16

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) ]
  Show Outcome Measure 17

18.  Secondary:   Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination   [ Time Frame: During a 4-day period after Nimenrix vaccination ]
  Hide Outcome Measure 18

Measure Type Secondary
Measure Title Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination
Measure Description Solicited local symptoms assessed include pain, redness and swelling.
Time Frame During a 4-day period after Nimenrix vaccination  
Safety Issue No  

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.
The analysis was done on the Total Vaccinated Cohort including all subjects with study vaccine administered and with a completed symptom sheet. Only subjects from the groups receiving Nimenrix were assessed.

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.

Measured Values
    Nimenrix + Twinrix Group     Nimenrix Group     Twinrix Group  
Number of Participants Analyzed  
[units: participants]
 		  365     119     0  
Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination  
[units: Subjects]
 		     
Pain     181     58      
Redness     75     19      
Swelling     62     18      

No statistical analysis provided for Number of Subjects Reporting Any Solicited Local Symptoms Post-meningococcal Vaccination



19.  Secondary:   Number of Subjects Reporting Any Solicited Local Symptoms Post-Twinrix Vaccination   [ Time Frame: During a 4-day period after each Twinrix vaccination ]
  Show Outcome Measure 19

20.  Secondary:   Number of Subjects Reporting Any Solicited General Symptoms   [ Time Frame: During a 4-day period after any vaccination ]
  Show Outcome Measure 20

21.  Secondary:   Number of Subjects Reporting Any Unsolicited Adverse Events (AEs)   [ Time Frame: Up to 1 month after each vaccine dose ]
  Show Outcome Measure 21

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) ]
  Show Outcome Measure 22

23.  Secondary:   Number of Subjects Reporting Any Rash   [ Time Frame: During the entire study (up to Month 7) ]
  Show Outcome Measure 23

24.  Secondary:   Number of Subjects Reporting Any Conditions Prompting Emergency Room Visits   [ Time Frame: During the entire study (up to Month 7) ]
  Show Outcome Measure 24

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
  Show Serious Adverse Events


  Other Adverse Events
  Show Other Adverse Events


  More Information
  Hide 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.


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.  


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