Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Immunogenicity and Safety Study of GSK Biologicals' Meningococcal Vaccine Given as One Dose to Healthy Subjects Above 56 Years

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01235975
First received: November 4, 2010
Last updated: March 20, 2017
Last verified: October 2016
Results First Received: March 20, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: No masking;   Primary Purpose: Prevention
Condition: Infections, Meningococcal
Interventions: Biological: Meningococcal vaccine GSK 134612
Biological: MencevaxACWY TM

  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 Group Healthy male or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
Mencevax Group Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.

Participant Flow:   Overall Study
    Nimenrix Group   Mencevax Group
STARTED   274   95 
COMPLETED   257   88 
NOT COMPLETED   17   7 
Serious Adverse Event                0                1 
Withdrawal by Subject                8                2 
Migrated/moved from study area                2                1 
Lost to Follow-up                7                3 



  Baseline Characteristics
  Hide 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 or female subjects aged 56 years or older received a single dose of Nimenrix™ conjugate vaccine, administered intramuscularly into the deltoid region of the non-dominant arm, at Day 0.
Mencevax Group Healthy male or female subjects aged 56 years or older received a single dose of Mencevax™ vaccine, administered by subcutaneous injection in the upper region of the non-dominant arm, at Day 0.
Total Total of all reporting groups

Baseline Measures
   Nimenrix Group   Mencevax Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 274   95   369 
Age 
[Units: Years]
Mean (Standard Deviation)
 64.1  (7.22)   64.3  (7.39)   64.15  (7.25) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      182  66.4%      70  73.7%      252  68.3% 
Male      92  33.6%      25  26.3%      117  31.7% 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Vaccine Response to Meningococcal Antigens (MenA, MenC, MenW-135 and MenY)   [ Time Frame: One month after vaccination (Month 1) ]

2.  Secondary:   Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value   [ Time Frame: At Day 0 (PRE) and Month 1 ]

3.  Secondary:   Number of Subjects With rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers ≥ the Cut-off Value   [ Time Frame: At Day 0 (PRE) and Month 1 ]

4.  Secondary:   rSBA-MenA, rSBA-MenC, rSBA-MenW-135 and rSBA-MenY Antibody Titers   [ Time Frame: At Day 0 (PRE) and Month 1 ]

5.  Secondary:   Number of Subjects With Anti-polysaccharide Meningococcal Serogroup A (Anti-PSA), Serogroup C (Anti-PSC), Serogroup W-135 (Anti-PSW-135) and Serogroup Y (Anti-PSY) Antibody Concentrations ≥ the Cut-off Value   [ Time Frame: At Day 0 (PRE) and Month 1 ]

6.  Secondary:   Number of Subjects With Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations ≥ the Cut-off Value   [ Time Frame: At Day 0 (PRE) and Month 1 ]

7.  Secondary:   Anti-PSA, Anti-PSC, Anti-PSW-135 and Anti-PSY Antibody Concentrations   [ Time Frame: At Day 0 (PRE) and Month 1 ]

8.  Secondary:   Number of Subjects With Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations ≥ the Cut-off Value   [ Time Frame: At Day 0 (PRE) and Month 1 ]

9.  Secondary:   Anti-tetanus Toxoid (Anti-TT) Antibody Concentrations   [ Time Frame: At Day 0 (PRE) and Month 1 ]

10.  Secondary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms   [ Time Frame: Within 4 days (Day 0 to 3) post-vaccination ]

11.  Secondary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: Within 4 days (Day 0 to 3) post-vaccination ]

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

13.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: Within 31 days (Day 0 to 30) after vaccination ]

14.  Secondary:   Number of Subjects With New Onset Chronic Illnesses (NOCI)   [ Time Frame: Within 31 days (Day 0 to 30) after vaccination ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide 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
  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.


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


Publications:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01235975     History of Changes
Other Study ID Numbers: 113807
Study First Received: November 4, 2010
Results First Received: March 20, 2017
Last Updated: March 20, 2017