ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 99 of 597 for:    Fluzone® | Studies With Results

Does Seasonal Influenza Vaccination Affect the Incidence of pH1N1 Influenza?

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.
ClinicalTrials.gov Identifier: NCT01001325
Recruitment Status : Completed
First Posted : October 26, 2009
Results First Posted : June 15, 2011
Last Update Posted : April 20, 2012
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
Mount Sinai Hospital, Canada

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Health Services Research
Condition Influenza
Interventions Biological: Fluviral influenza vaccine, 2009-2010
Biological: Normal saline
Enrollment 468

Recruitment Details

Enrolment start: October 5, 2009 Enrolment complete: February 3, 2010

Enrolment was conducted from a variety of work places and university settings.

Pre-assignment Details  
Arm/Group Title Seasonal Influenza Vaccination Placebo
Hide Arm/Group Description Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification 0.5 mL normal saline
Period Title: Overall Study
Started 234 234
Completed 216 224
Not Completed 18 10
Reason Not Completed
Lost to Follow-up             16             10
Protocol Violation             2             0
Arm/Group Title Seasonal Influenza Vaccination Placebo Total
Hide Arm/Group Description Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification 0.5 mL normal saline Total of all reporting groups
Overall Number of Baseline Participants 234 234 468
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 234 participants 234 participants 468 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
233
  99.6%
234
 100.0%
467
  99.8%
>=65 years
1
   0.4%
0
   0.0%
1
   0.2%
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 234 participants 234 participants 468 participants
36.8  (12.6) 35.7  (12.5) 36.3  (12.5)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 234 participants 234 participants 468 participants
Female
148
  63.2%
157
  67.1%
305
  65.2%
Male
86
  36.8%
77
  32.9%
163
  34.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Canada Number Analyzed 234 participants 234 participants 468 participants
234 234 468
1.Primary Outcome
Title Number of pH1N1 Influenza Infections as Diagnosed by PCR From Mid-turbinate Swab
Hide Description Influenza infection (pH1N1) as diagnosed by PCR from self-collected mid-turbinate swab. Participant is asked to collect a swab when they have symptoms possibly compatible with an acute viral respiratory illness: 1) fever without another obvious source, 2) at least two new respiratory symptoms (runny or stuffy nose, sneezing, sore or scratchy throat, hoarseness, cough), or 3) one respiratory symptom (as above) and one systemic symptom (fever, malaise, muscle aches, headache, fatigue)
Time Frame day +7 post seasonal influenza vaccination (or placebo) to end of study
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Seasonal Influenza Vaccination Placebo
Hide Arm/Group Description:
Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
0.5 mL normal saline
Overall Number of Participants Analyzed 234 234
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: participants
2
(0.23 to 6.55)
4
(1.17 to 9.59)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Seasonal Influenza Vaccination, Placebo
Comments

Null hypothesis: There is no difference in incidence of pandemic strain influenza infection for people given seasonal influenza vaccine compared to those given a placebo.

Power to detect a 2-fold difference if attack rate in non-vaccinated participants is 10%: 86%

Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.685
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Time Frame Enrolment to March 28, 2010 - Maximum: 6 months
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Seasonal Influenza Vaccination Placebo
Hide Arm/Group Description Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification 0.5 mL normal saline
All-Cause Mortality
Seasonal Influenza Vaccination Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Seasonal Influenza Vaccination Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/234 (0.43%)      1/234 (0.43%)    
Congenital, familial and genetic disorders     
death  1 [1]  0/234 (0.00%)  0 1/234 (0.43%)  1
Respiratory, thoracic and mediastinal disorders     
pneumonia  1  1/234 (0.43%)  1 0/234 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA (10.0)
[1]
Not related to study drug
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Seasonal Influenza Vaccination Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/234 (0.00%)      0/234 (0.00%)    
A major limitation to this study was the date of enrolment for the subjects: only 249 (53%) of the subjects were enrolled by the end of second wave of the pandemic (and a third wave did not occur before the end of the study).
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.
Results Point of Contact
Name/Title: Dr. Brenda Coleman
Organization: Mount Sinai Hospital
Phone: 416-586-4800 ext 4161
Responsible Party: Mount Sinai Hospital, Canada
ClinicalTrials.gov Identifier: NCT01001325     History of Changes
Other Study ID Numbers: CRT113936
First Submitted: October 23, 2009
First Posted: October 26, 2009
Results First Submitted: May 13, 2011
Results First Posted: June 15, 2011
Last Update Posted: April 20, 2012