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Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine GSK 134612 Versus Menactra® in Healthy Adolescents/Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01165242
First Posted: July 19, 2010
Last Update Posted: June 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
Results First Submitted: May 11, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Infections, Meningococcal
Interventions: Biological: Meningococcal vaccine GSK 134612
Biological: Menactra®

  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
Out of the 1013 subjects enrolled in this study, 2 were assigned subject numbers but received no vaccination and were hence excluded from the study start.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
During the screening the following steps occurred: check for inclusion/exclusion criteria, contraindications/precautions, medical history of the subjects and signing informed consent forms.

Reporting Groups
  Description
Nimenrix Lot A Group Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Nimenrix Lot B Group Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Menactra Group Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.

Participant Flow:   Overall Study
    Nimenrix Lot A Group   Nimenrix Lot B Group   Menactra Group
STARTED   337   336   338 
COMPLETED   327   326   324 
NOT COMPLETED   10   10   14 
Unreachable Subjects                1                0                0 
Incarcerated Subjects                0                1                0 
Visit 2 Declined by Subject                0                0                1 
Withdrawal by Subject                0                2                2 
Extended Holiday                0                0                1 
Lost to Follow-up                9                7                10 



  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
Nimenrix Lot A Group Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot A vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Nimenrix Lot B Group Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Nimenrix™ Lot B vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Menactra Group Healthy male and female subjects between, and including, 10 and 25 years of age, who received 1 dose of Menactra® vaccine, administered intramuscularly in the deltoid region of the non-dominant arm.
Total Total of all reporting groups

Baseline Measures
   Nimenrix Lot A Group   Nimenrix Lot B Group   Menactra Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 337   336   338   1011 
Age 
[Units: Years]
Mean (Standard Deviation)
 16.4  (5.16)   16.3  (5.16)   16.2  (4.97)   16.30  (5.09) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      175  51.9%      169  50.3%      176  52.1%      520  51.4% 
Male      162  48.1%      167  49.7%      162  47.9%      491  48.6% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
       
African Heritage/African American   38   29   40   107 
American Indian or Alaskan Native   4   2   1   7 
Asian-Central/South Asian Heritage   17   17   17   51 
Asian-East Asian Heritage   4   3   5   12 
Asian-Japanese Heritage   0   2   0   2 
Asian-South East Asian Heritage   4   3   2   9 
White-Arabic/North African Heritage   2   3   2   7 
White-Caucasian/European Heritage   248   249   257   754 
Not specified   20   28   14   62 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Subjects With Vaccine Response to Serum Bactericidal Assay Using Human Complement Against Neisseria Meningitidis Serogroup A, C, W-135 and Y (hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY) Antibodies   [ Time Frame: One month after vaccination (Month 1) ]

2.  Secondary:   Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value   [ Time Frame: Prior to (PRE) and one month after vaccination (Month 1) ]

3.  Secondary:   Number of Subjects With hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers ≥ the Cut-off Value   [ Time Frame: Prior to (PRE) and one month after vaccination (Month 1) ]

4.  Secondary:   hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibody Titers   [ Time Frame: Prior to (PRE) and one month after vaccination (Month 1) ]

5.  Secondary:   Number of Subjects With Vaccine Response for hSBA-MenA, hSBA-MenC, hSBA-MenW-135 and hSBA-MenY Antibodies   [ Time Frame: One month after vaccinattion (Month 1) ]

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

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

8.  Secondary:   Number of Subjects With Any Unsolicited Adverse Events (AEs)   [ Time Frame: Within 31 days (Day 0-30) post-vaccination ]

9.  Secondary:   Number of Subjects With New Onset of Chronic Illness(es) (NOCI)   [ Time Frame: From Month 0 through Month 6 ]

10.  Secondary:   Number of Subjects With Any Serious Adverse Events (SAEs)   [ Time Frame: From Month 0 through Month 6 ]


  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 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: NCT01165242     History of Changes
Other Study ID Numbers: 114249
First Submitted: July 15, 2010
First Posted: July 19, 2010
Results First Submitted: May 11, 2017
Results First Posted: June 8, 2017
Last Update Posted: June 8, 2017