Trial to Evaluate the Efficacy of GSK Biologicals' Influenza Vaccine GSK2186877A in Adults 65 Year of Age and Older

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT00753272
First received: September 12, 2008
Last updated: July 11, 2013
Last verified: November 2012
Results First Received: April 26, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition: Influenza Disease
Interventions: Biological: GSK Bio's influenza vaccine GSK2186877A
Biological: Fluarix TM

  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
Subjects were vaccinated during the pre-influenza season at Day 0, were contacted by phone during the surveillance period from mid November to the end of the influenza season (April-May) and were contacted by phone at Days 270 and 365 for the Year 1 influenza season 2008/2009 and the Year 2 influenza season 2009/2010.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
For lot-to-lot consistency analyses after Dose 1 at Day 0 of the Year 1, FluNG Group was divided in 3 sub-groups: FluNG Lot 1 Group, FluNG Lot 2 Group and FluNG Lot 3 Group: subjects received 1 dose of FluNG vaccine Lot 1, 2 or 3 at Day 0 of the Year 1. They all received Dose 2 at Day 0 of the Year 2, again from 3 different lots.

Reporting Groups
  Description
FluNG Group subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
Fluarix Group subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).

Participant Flow:   Overall Study
    FluNG Group     Fluarix Group  
STARTED     21893     21802  
COMPLETED     16911     16895  
NOT COMPLETED     4982     4907  
Adverse Event                 878                 869  
Protocol Violation                 28                 46  
Withdrawal by Subject                 2481                 2407  
Lost to Follow-up                 491                 497  
Unspecified                 1104                 1088  



  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
FluNG Group subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
Fluarix Group subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
Total Total of all reporting groups

Baseline Measures
    FluNG Group     Fluarix Group     Total  
Number of Participants  
[units: participants]
  21893     21802     43695  
Age  
[units: Years]
Mean ± Standard Deviation
     
Years     73.5  ± 6.09     73.5  ± 6.16     73.5  ± 6.13  
Gender  
[units: Subjects]
     
Female     12549     12422     24971  
Male     9344     9380     18724  



  Outcome Measures
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1.  Primary:   Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.   [ Time Frame: After the first dose during the corresponding surveillance period (from mid November 2008 to the end of April 2009 (end of influenza season)) ]

2.  Primary:   Serum Hemagglutination-inhibition (HI) Antibody Titers, Against Each of the 3 Vaccine Influenza Strains, in the FluNG Groups.   [ Time Frame: At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study ]

3.  Secondary:   Number of Subjects Reporting Polymerase Chain Reaction (PCR)-Confirmed Influenza A and/or B Infection.   [ Time Frame: During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010) ]

4.  Secondary:   Number of Subjects Reporting Culture-confirmed Influenza A and/or B Infection.   [ Time Frame: During the whole surveillance period (from mid November 2008 to end of April 2009 and from mid November 2009 to end of April 2010) ]

5.  Secondary:   Number of Subjects Reporting Pneumonia or Clinical Influenza After the First Dose of Vaccine.   [ Time Frame: During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009) ]

6.  Secondary:   Number of Subjects Reporting All-cause Death After the First Dose of Vaccine.   [ Time Frame: During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009) ]

7.  Secondary:   Number of Subjects Reporting Hospitalization Due to Respiratory Diseases After the First Dose of Vaccine   [ Time Frame: During the influenza peak season within the first surveillance period (the influenza peak season being defined per country, falling somewhere between mid November 2008 to end of April 2009) ]

8.  Secondary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).   [ Time Frame: Within 365 days after the first dose (from Dose 1 at Day 0 up to Day 365 for the Year 2008/2009) ]

9.  Secondary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).   [ Time Frame: Within 365 days after the second dose (from Dose 1 at Day 0 up to Day 365 for the Year 2009/2010) ]

10.  Secondary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Adverse Events (AEs) of Specific Interest Including Autoimmune Disease (AID).   [ Time Frame: During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010) ]

11.  Secondary:   Number of Subjects Reporting Any and Related to Vaccination Serious Adverse Events (SAEs).   [ Time Frame: During the entire study period (during the 365 days of follow-up after each vaccination at Year 2008/2009 and Year 2009/2010) ]

12.  Secondary:   Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms.   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009) ]

13.  Secondary:   Number of Days With Any Grade of Solicited Local Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009) ]

14.  Secondary:   Number of Subjects Reporting Any and Severe (Grade 3) Solicited Local Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010) ]

15.  Secondary:   Number of Days With Any Grade of Solicited Local Symptoms.   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010) ]

16.  Secondary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Solicited General Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009) ]

17.  Secondary:   Number of Days With Any Grade of Solicited General Symptoms   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the first year (2008/2009) ]

18.  Secondary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010) ]
  Hide Outcome Measure 18

Measure Type Secondary
Measure Title Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.
Measure Description Solicited general symptoms assessed were arthralgia, fatigue, gastrointestinal, headache, myalgia, shivering and temperature (defined as oral temperature equal to or above (≥) 38.0 degrees Celsius). Any = incidence of a particular symptom regardless of intensity grade or relationship to vaccination. Grade 3 = general symptom which prevented normal everyday activities. Related = general symptom assessed by the investigator as causally related to the study vaccination. Grade 3 temperature = oral temperature ≥39.0°C - ≤ 40.0°C.
Time Frame During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010)  
Safety Issue No  

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.
The Two-Dose Total Vaccinated cohort for the safety subset included all subjects with at least one vaccine administration documented in each year of the study and included in the safety subset.

Reporting Groups
  Description
FluNG Group subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
Fluarix Group subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).

Measured Values
    FluNG Group     Fluarix Group  
Number of Participants Analyzed  
[units: participants]
  2436     2489  
Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.  
[units: Subjects]
   
Any arthralgia     258     176  
Grade 3 arthralgia     10     4  
Related arthralgia     169     90  
Any fatigue     457     318  
Grade 3 fatigue     8     6  
Related fatigue     307     169  
Any gastrointestinal     137     124  
Grade 3 gastrointestinal     5     8  
Related gastrointestinal     71     46  
Any headache     342     237  
Grade 3 headache     10     4  
Related headache     219     119  
Any myalgia     380     209  
Grade 3 myalgia     11     6  
Related myalgia     261     117  
Any shivering     189     88  
Grade 3 shivering     11     6  
Related shivering     127     44  
Temperature >= 38.0°C     52     25  
Temperature >= 39.0°C - <= 40.0°C     5     2  
Related temperature     33     7  

No statistical analysis provided for Number of Subjects Reporting Any, Severe (Grade 3) and Related Solicited General Symptoms.



19.  Secondary:   Number of Days With Any Grade of Solicited General Symptoms.   [ Time Frame: During the 7-day (Days 0-6) post-vaccination period, the second year (2009/2010) ]

20.  Secondary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).   [ Time Frame: Within 21 days (Days 0-20) after the first dose (Year 2008/2009) ]

21.  Secondary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited Adverse Events (AEs).   [ Time Frame: Within 21 days (Days 0-20) after the second dose (Year 2009/2010) ]

22.  Secondary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit   [ Time Frame: Within 180 days (Days 0-179) after the first dose (Year 2008/2009) ]

23.  Secondary:   Number of Subjects Reporting Any, Severe (Grade 3) and Related to Vaccination Unsolicited AEs With Medically Attended Visit.   [ Time Frame: Within 180 days (Days 0-179) after the second dose (Year 2009/2010) ]

24.  Secondary:   Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.   [ Time Frame: At Days 0 (pre-vaccination Dose 1) and 21 (post-vaccination Dose 1) of the first year (2008/2009) of the study ]

25.  Secondary:   Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains   [ Time Frame: At Days 0 (pre-vaccination Dose 2) and 21 (post-vaccination Dose 2) of the second year (2009/2010) of the study ]

26.  Secondary:   Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.   [ Time Frame: At Days 0 (pre-vaccination Dose 1), 21 (post-vaccination Dose 1) and 180 (post-vaccination Dose 1) of the first year (2008/2009) of the study ]
  Hide Outcome Measure 26

Measure Type Secondary
Measure Title Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.
Measure Description Vaccine strains assessed were A/Brisbane/59/2077, A/Uruguay/716/2007 and B/Brisbane/3/2007. Titers were expressed as geometric mean titers calculated on all subjects for 600 subjects in the persistence subset only.
Time Frame At Days 0 (pre-vaccination Dose 1), 21 (post-vaccination Dose 1) and 180 (post-vaccination Dose 1) of the first year (2008/2009) of the study  
Safety Issue No  

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.
The One-Dose According-To-Protocol cohort for persistence included evaluable subjects for whom data concerning immunogenicity outcome measures were available in terms of antibodies against at least one study vaccine antigen component at Day 180 of the first year of the study.

Reporting Groups
  Description
FluNG Group subjects received 2 doses (1 dose per season) of FluNG vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).
Fluarix Group subjects received 2 doses (1 dose per season) of Fluarix™ vaccine during the Northern Hemisphere (NH) vaccination periods. One dose at Day 0 of the Year 1 and one dose at Day 0 of the Year 2 (= Day 365 Year 1).

Measured Values
    FluNG Group     Fluarix Group  
Number of Participants Analyzed  
[units: participants]
  268     267  
Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.  
[units: Titers]
Geometric Mean ( 95% Confidence Interval )
   
A/Brisbane [Day 0] (N=268,265)     15.4  
  ( 13.7 to 17.4 )  
  13.9  
  ( 12.4 to 15.6 )  
A/Brisbane [Day 21] (N=268,267)     75.4  
  ( 66.3 to 85.9 )  
  64.5  
  ( 55.7 to 74.7 )  
A/Brisbane [Day 180] (N=268,267)     30.4  
  ( 26.8 to 34.4 )  
  28.1  
  ( 24.8 to 31.8 )  
A/Uruguay [Day 0] (N=268,265)     19.3  
  ( 16.5 to 22.6 )  
  17.8  
  ( 15.3 to 20.7 )  
A/Uruguay [Day 21] (N=268,267)     275.0  
  ( 233.1 to 324.5 )  
  165.0  
  ( 139.0 to 195.9 )  
A/Uruguay [Day 180] (N=268,267)     97.7  
  ( 82.3 to 116.0 )  
  64.0  
  ( 53.7 to 76.3 )  
B/Brisbane [Day 0] (N=268,265)     89.3  
  ( 76.6 to 104.2 )  
  83.8  
  ( 72.3 to 97.1 )  
B/Brisbane [Day 21] (N=268,267)     573.4  
  ( 517.5 to 635.3 )  
  478.5  
  ( 422.4 to 541.9 )  
A/Brisbane [Day 180] (N=268,267)     274.6  
  ( 246.5 to 305.9 )  
  262.3  
  ( 234.7 to 293.1 )  

No statistical analysis provided for Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.



27.  Secondary:   Serum Hemagglutination-inhibition (HI) Antibody Titer Against Each of the 3 Vaccine Influenza Strains.   [ Time Frame: At Days 0 (pre-vaccination Dose 2), 21 (post-vaccination Dose 2) and 180 (post-vaccination Dose 2) of the second year (2009/2010) of the study ]

28.  Secondary:   Number of Seroconverted Subjects for HI Antibodies Against Each of the 3 Vaccine Influenza Strains   [ Time Frame: At Day 21 of the first year (2008/2009) of the study. ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


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


No publications provided by GlaxoSmithKline

Publications automatically indexed to this study:

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT00753272     History of Changes
Other Study ID Numbers: 106372
Study First Received: September 12, 2008
Results First Received: April 26, 2012
Last Updated: July 11, 2013
Health Authority: Estonia: State Agency of Medicines
Czech Republic: Státní ústav pro kontrolu léčiv, Oddělení klinického hodnocení
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Belgium: Agence Fédérale des Médicaments et des Produits de la Santé
Romania: Agentia Nationala a Medicamentului
Germany: Land Authority for Health and Social Issues
Norway: Statens Legemiddelverk
Taiwan: Department of Health
Russia: Russian Ministry of Health
Poland: URZ.D REJESTRACJI PRODUKTÓW LECZNICZYCH, WYROBÓW MEDYCZNYCH I PRODUKTÓW BIOBÓJCZYCH,CEBK
Canada: Health Canada
Mexico: Ministry of Health
France: Agence Française de Sécurité Sanitaire des Produits de Santé
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)