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Study to Evaluate the Immune Response and the Safety of Fluarix TM/ Influsplit SSW® 2010/2011 or Pandemrix TM

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ClinicalTrials.gov Identifier: NCT01160237
Recruitment Status : Terminated (The study was terminated for logistic reasons not related to safety or efficacy of the vaccine.)
First Posted : July 12, 2010
Results First Posted : March 23, 2012
Last Update Posted : October 20, 2016
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Influenza
Interventions Biological: PandemrixTM
Biological: FluarixTM/ Influsplit SSW® 2010/2011
Enrollment 7
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Pandemrix Group Fluarix Group Control Group
Hide Arm/Group Description Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix. Subjects previously vaccinated with Pandemrix received one dose of Fluarix. Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
Period Title: Overall Study
Started 4 3 0
Completed 4 3 0
Not Completed 0 0 0
Arm/Group Title Pandemrix Group Fluarix Group Control Group Total
Hide Arm/Group Description Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix. Subjects previously vaccinated with Pandemrix received one dose of Fluarix. Subjects not previously vaccinated with Pandemrix received one dose of Fluarix. Total of all reporting groups
Overall Number of Baseline Participants 4 3 0 7
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 3 participants 0 participants 7 participants
61.3  (9.50) 55.3  (18.80) 58.7  (13.16)
Gender  
Measure Type: Number
Unit of measure:  Subjects
Number Analyzed 4 participants 3 participants 0 participants 7 participants
Female 3 2 5
Male 1 1 2
1.Primary Outcome
Title Humoral Immune Response in Terms of Haemagglutination Inhibition (HI) Antibodies for Each Vaccine Strain, in Subjects Aged 18-60 and Above 60 Years
Hide Description [Not Specified]
Time Frame 21 days after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.
Arm/Group Title Pandemrix Group Fluarix Group Control Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
2.Secondary Outcome
Title Solicited Local and General Symptoms
Hide Description [Not Specified]
Time Frame During 7 days (Day 0 - Day 6) after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.
Arm/Group Title Pandemrix Group Fluarix Group Control Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
3.Secondary Outcome
Title Number of Subjects Reporting Unsolicited Adverse Events
Hide Description [Not Specified]
Time Frame During 31 days (Day 0 - Day 30) after vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the total vaccinated cohort. No subjects were enrolled in the Control Group by the time the study was prematurely terminated.
Arm/Group Title Pandemrix Group Fluarix Group Control Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
Overall Number of Participants Analyzed 4 3 0
Measure Type: Number
Unit of Measure: subjects
0 2
4.Secondary Outcome
Title Number of Subjects Reporting Serious Adverse Events
Hide Description [Not Specified]
Time Frame During the whole study period (Day 0 - Day 182)
Hide Outcome Measure Data
Hide Analysis Population Description
The analysis was performed on the total vaccinated cohort. No subjects were enrolled in the Control Group by the time the study was prematurely terminated.
Arm/Group Title Pandemrix Group Fluarix Group Control Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
Overall Number of Participants Analyzed 4 3 0
Measure Type: Number
Unit of Measure: subjects
1 0
5.Secondary Outcome
Title Potential Immune Mediated Diseases
Hide Description [Not Specified]
Time Frame During the whole study period (Day 0 - Day 182)
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.
Arm/Group Title Pandemrix Group Fluarix Group Control Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
6.Secondary Outcome
Title Humoral Immune Response in Terms of HI Antibodies Against Each Vaccine Strain, at Different Timepoints in Subjects Aged 18-60 and Above 60 Years
Hide Description [Not Specified]
Time Frame At Days 0, 7 and 182
Hide Outcome Measure Data
Hide Analysis Population Description
This outcome measure was not assessed for any of the study groups since the study was terminated prematurely.
Arm/Group Title Pandemrix Group Fluarix Group Control Group
Hide Arm/Group Description:
Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix.
Subjects previously vaccinated with Pandemrix received one dose of Fluarix.
Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
Overall Number of Participants Analyzed 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Pandemrix Group Fluarix Group Control Group
Hide Arm/Group Description Subjects previously vaccinated with Pandemrix received 1 dose of Pandemrix. Subjects previously vaccinated with Pandemrix received one dose of Fluarix. Subjects not previously vaccinated with Pandemrix received one dose of Fluarix.
All-Cause Mortality
Pandemrix Group Fluarix Group Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Pandemrix Group Fluarix Group Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/4 (25.00%)   0/3 (0.00%)   0/0 
Injury, poisoning and procedural complications       
femoral neck fracture *  1/4 (25.00%)  0/3 (0.00%)  0/0 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Pandemrix Group Fluarix Group Control Group
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   2/3 (66.67%)   0/0 
Cardiac disorders       
Hypertension *  0/4 (0.00%)  1/3 (33.33%)  0/0 
Infections and infestations       
Upper respiratory tract infection *  0/4 (0.00%)  1/3 (33.33%)  0/0 
*
Indicates events were collected by non-systematic assessment
Only 7 subjects were enrolled in either the Pandemrix Group or the Fluarix Group and none in the Control Group since the study was terminated prematurely. Therefore most outcome measures (except unsolicited AEs and SAEs) were not analysed.
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.
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
Layout table for additonal information
Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01160237     History of Changes
Other Study ID Numbers: 114454
First Submitted: July 8, 2010
First Posted: July 12, 2010
Results First Submitted: February 21, 2012
Results First Posted: March 23, 2012
Last Update Posted: October 20, 2016