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Immunogenicity and Safety Study of GlaxoSmithKline (GSK) Biologicals' Fluviral® (2012/2013 Season) in Adults

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01626820
First Posted: June 25, 2012
Last Update Posted: September 23, 2016
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: August 8, 2013  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Influenza
Intervention: Biological: Fluviral®

  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
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
At least 50% of the subjects in Fluviral Adults and Fluviral Elderly Groups had not been previously immunized with influenza vaccine in the 2011/2012 season.

Reporting Groups
  Description
Fluviral Adults Group Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
Fluviral Elderly Group Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm at Day 0

Participant Flow:   Overall Study
    Fluviral Adults Group   Fluviral Elderly Group
STARTED   56   57 
COMPLETED   56   57 
NOT COMPLETED   0   0 



  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
Fluviral Adults Group Subjects 18-60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0.
Fluviral Elderly Group Subjects above 60 years of age received 1 dose of Fluviral® vaccine, administered intramuscularly in the deltoid of the non-dominant arm, at Day 0
Total Total of all reporting groups

Baseline Measures
   Fluviral Adults Group   Fluviral Elderly Group   Total 
Overall Participants Analyzed 
[Units: Participants]
 56   57   113 
Age 
[Units: Years]
Mean (Standard Deviation)
 39.80  (12.32)   68.30  (5.28)   54.18  (17.13) 
Gender 
[Units: Subjects]
     
Female   34   33   67 
Male   22   24   46 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Haemagglutination Inhibition (HI) Antibody Titers, Against Each of the Vaccine Influenza Virus Strains.   [ Time Frame: At Day 0 and Day 21 ]

2.  Primary:   Number of Subjects Seroprotected for HI Antibodies Against Each of the Three Vaccine Influenza Strains.   [ Time Frame: At Day 0 and Day 21 ]

3.  Primary:   Number of Seroconverted Subjects for HI Antibodies Against Each of the Three Vaccine Influenza Strains.   [ Time Frame: At Day 21 ]

4.  Primary:   Mean Geometric Increase (MGI) for HI Antibody Titer Against Each of the Three Vaccine Influenza Strains.   [ Time Frame: At Day 21 ]

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

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

7.  Secondary:   Number of Subjects Reporting Any Unsolicited Adverse Events (AEs).   [ Time Frame: During the 21-day (Days 0-20) post-vaccination period. ]

8.  Secondary:   Number of Subjects Reporting Any and Related Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period (Day 0 - Day 20 after vaccination). ]


  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



Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01626820     History of Changes
Other Study ID Numbers: 116664
First Submitted: June 21, 2012
First Posted: June 25, 2012
Results First Submitted: August 8, 2013
Results First Posted: October 14, 2013
Last Update Posted: September 23, 2016