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Non-Inferiority of Meningococcal Vaccine GSK134612 Versus Mencevax™ in 11-17 Year-Old Subjects

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ClinicalTrials.gov Identifier: NCT00464815
Recruitment Status : Completed
First Posted : April 24, 2007
Results First Posted : April 2, 2018
Last Update Posted : June 8, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Infections, Meningococcal
Interventions: Biological: Meningococcal vaccine GSK134612
Biological: Mencevax™ ACWY

  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
The target sample size was 1024 enrolled subjects, but a total of 1025 subjects (in all age strata) were actually enrolled and vaccinated in seven study centres in India, Taiwan and the Philippines.

Reporting Groups
  Description
Nimenrix Group Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
Mencevax ACWY Group Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.

Participant Flow:   Overall Study
    Nimenrix Group   Mencevax ACWY Group
STARTED   768   257 
COMPLETED   762   254 
NOT COMPLETED   6   3 
Withdrawal by Subject                6                3 



  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.
No text entered.

Reporting Groups
  Description
Nimenrix Group Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Nimenrix (GSK134612) vaccine, administered intramuscularly into the deltoid region of the non-dominant arm.
Mencevax ACWY Group Healthy male and female subjects aged 11 through 17 years, who received 1 dose of Mencevax ACWY vaccine, administered subcutaneously into the non-dominant upper arm.
Total Total of all reporting groups

Baseline Measures
   Nimenrix Group   Mencevax ACWY Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 768   257   1025 
Age 
[Units: Years]
Mean (Standard Deviation)
 14.3  (1.97)   14.3  (1.97)   14.3  (1.97) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      414  53.9%      135  52.5%      549  53.6% 
Male      354  46.1%      122  47.5%      476  46.4% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Geographic ancestry       
Asian-Central/South Asian heritage      296  38.5%      100  38.9%      396  38.6% 
Asian-East Asian heritage      175  22.8%      59  23.0%      234  22.8% 
Asian-South East Asian heritage      297  38.7%      98  38.1%      395  38.5% 


  Outcome Measures

1.  Primary:   Number of Subjects With Vaccine Response to Meningococcal Antigens   [ Time Frame: One month post-vaccination (At Month 1) ]

2.  Primary:   Number of Subjects With Any Grade 3 General (Solicited and Unsolicited) Symptoms   [ Time Frame: During the 4-day (Days 0-3) period after vaccination ]

3.  Secondary:   Number of Subjects With rSBA-Men Antibody Titers ≥ the Cut-off Values   [ Time Frame: Prior to (Month 0) and one month after vaccination (Month 1) ]

4.  Secondary:   Meningococcal rSBA Antibody Titers   [ Time Frame: Prior to (Month 0) and one month after vaccination (Month 1) ]

5.  Secondary:   Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Greater Than (>) the Cut-off Value   [ Time Frame: Prior to (Month 0) and one month after vaccination (Month 1) ]

6.  Secondary:   Anti-TT Antibody Concentrations   [ Time Frame: Prior to (Month 0) and one month after vaccination (Month 1) ]

7.  Secondary:   Number of Subjects With Anti-meningococcal Polysaccharides (PS) Antibody Concentrations ≥ the Cut-off Values   [ Time Frame: Prior to (Month 0) and one month after vaccination (Month 1) ]

8.  Secondary:   Anti-meningococcal Polysaccharide Concentrations   [ Time Frame: Prior to (Month 0) and one month after vaccination (Month 1) ]

9.  Secondary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms   [ Time Frame: During the 4-day (Days 0-3) period after vaccination ]

10.  Secondary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: During the 4-day (Days 0-3) period after vaccination ]

11.  Secondary:   Number of Subjects With Any Unsolicited Adverse Events   [ Time Frame: During the 31-day (Days 0-30) post-vaccination period ]

12.  Secondary:   Number of Subjects With Any Serious Adverse Events (SAEs)   [ Time Frame: Up to study end (Month 6) ]

13.  Secondary:   Number of Subjects With Specific Adverse Events   [ Time Frame: Up to study end (Month 6) ]


  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 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.


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


Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00464815     History of Changes
Other Study ID Numbers: 109069
First Submitted: April 23, 2007
First Posted: April 24, 2007
Results First Submitted: May 31, 2017
Results First Posted: April 2, 2018
Last Update Posted: June 8, 2018