We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Study of GSK Biologicals' Influenza Vaccine Arepanrix™ in Japanese Adults 65 Years of Age or Older

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01114620
First Posted: May 3, 2010
Last Update Posted: December 14, 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 8, 2017  
Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition: Influenza
Intervention: Biological: Arepanrix™

  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
Arepanrix Group Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.

Participant Flow:   Overall Study
    Arepanrix Group
STARTED   50 
COMPLETED   50 
NOT COMPLETED   0 



  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
Arepanrix Group Healthy Japanese male and female adults, 65 years of age or older, who received one dose of the study vaccine Arepanrix™, administered intramuscularly in the deltoid region of the non-dominant arm at Day 0.

Baseline Measures
   Arepanrix Group 
Overall Participants Analyzed 
[Units: Participants]
 50 
Age 
[Units: Years]
Mean (Standard Deviation)
 69.8  (4.17) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
 
Female      21  42.0% 
Male      29  58.0% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
 
Asian - Japanese heritage   50 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Number of Seroconverted Subjects for Hemagglutination Inhibition (HI) Antibodies   [ Time Frame: At Day 21 ]

2.  Primary:   Number of Seroprotected Subjects for HI Antibodies   [ Time Frame: At Day 21 ]

3.  Primary:   Geometric Mean Fold Rise (GMFR) for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease   [ Time Frame: At Day 21 ]

4.  Secondary:   Number of Subjects With HI Antibody Concentrations Above the Cut-off Value   [ Time Frame: At Days 0 and 21 ]

5.  Secondary:   Number of Subjects With HI Antibody Concentrations Above the Cut-off Value   [ Time Frame: At Days 0 and 182 ]

6.  Secondary:   Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain   [ Time Frame: At Days 0 and 21 ]

7.  Secondary:   Titers for Serum HI Antibodies Against Flu A/California/7/2009 Strain   [ Time Frame: At Days 0 and 182 ]

8.  Secondary:   Number of Seroconverted Subjects for HI Antibodies   [ Time Frame: At Day 182 ]

9.  Secondary:   Number of Seroprotected Subjects for HI Antibodies   [ Time Frame: At Days 0 and 182 ]

10.  Secondary:   GMFR for HI Antibodies Against Flu A/California/7/2009 Strain of Influenza Disease   [ Time Frame: At Day 182 ]

11.  Secondary:   Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value   [ Time Frame: At Days 0 and 21 ]

12.  Secondary:   Number of Subjects With Neutralizing Antibody Concentrations Above the Cut-off Value   [ Time Frame: At Days 0 and 182 ]

13.  Secondary:   Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease   [ Time Frame: At Days 0 and 21 ]

14.  Secondary:   Titers for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease   [ Time Frame: At Days 0 and 182 ]

15.  Secondary:   Number of Subjects With Vaccine Response Rate (VRR) for Neutralizing Antibodies Against Flu A/Netherlands/602/09 Strain of Influenza Disease   [ Time Frame: At Day 21 ]

16.  Secondary:   Number of Subjects With VRR for Neutralizing Antibodies Against Flu A/Netherlands/602/2009 Strain of Influenza Disease   [ Time Frame: At Day 182 ]

17.  Secondary:   Number of Subjects With Any and Grade 3 Solicited Local Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period ]

18.  Secondary:   Number of Days With Solicited Local Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period ]

19.  Secondary:   Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period ]

20.  Secondary:   Number of Days With Solicited General Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period ]

21.  Secondary:   Number of Subjects With Medically Attended AEs (MAEs)   [ Time Frame: During the 21-day (Days 0-20) post-vaccination period ]

22.  Secondary:   Number of Subjects With MAEs   [ Time Frame: During the 42-day (Days 0-41) post-vaccination period ]

23.  Secondary:   Number of Subjects With Potential Immune-mediated Diseases (pIMDs)   [ Time Frame: During the entire study period (from Day 0 up to Day 182) ]

24.  Secondary:   Number of Subjects With Normal or Abnormal Hematological and Biochemical Levels   [ Time Frame: At Day 0 and Day 7 ]

25.  Secondary:   Number of Subjects With Abnormal Urine Sampling Parameters   [ Time Frame: At Day 0 and Day 7 ]

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

27.  Secondary:   Number of Subjects With Unsolicited AEs   [ Time Frame: During the 42-day (Days 0-41) post-vaccination period ]

28.  Secondary:   Number of Subjects With Serious Adverse Events (SAEs)   [ Time Frame: During the entire study period (from Day 0 up to Day 182) ]


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01114620     History of Changes
Other Study ID Numbers: 114270
First Submitted: April 29, 2010
First Posted: May 3, 2010
Results First Submitted: May 8, 2017
Results First Posted: December 14, 2017
Last Update Posted: December 14, 2017