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Trial Outcomes & Findings for Does Seasonal Influenza Vaccination Affect the Incidence of pH1N1 Influenza? (NCT NCT01001325)

NCT ID: NCT01001325

Last Updated: 2012-04-20

Results Overview

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)

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

468 participants

Primary outcome timeframe

day +7 post seasonal influenza vaccination (or placebo) to end of study

Results posted on

2012-04-20

Participant Flow

Enrolment start: October 5, 2009 Enrolment complete: February 3, 2010 Enrolment was conducted from a variety of work places and university settings.

Participant milestones

Participant milestones
Measure
Seasonal Influenza Vaccination
Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
Placebo
0.5 mL normal saline
Overall Study
STARTED
234
234
Overall Study
COMPLETED
216
224
Overall Study
NOT COMPLETED
18
10

Reasons for withdrawal

Reasons for withdrawal
Measure
Seasonal Influenza Vaccination
Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
Placebo
0.5 mL normal saline
Overall Study
Lost to Follow-up
16
10
Overall Study
Protocol Violation
2
0

Baseline Characteristics

Does Seasonal Influenza Vaccination Affect the Incidence of pH1N1 Influenza?

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Seasonal Influenza Vaccination
n=234 Participants
Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
Placebo
n=234 Participants
0.5 mL normal saline
Total
n=468 Participants
Total of all reporting groups
Age, Categorical
<=18 years
0 Participants
n=5 Participants
0 Participants
n=7 Participants
0 Participants
n=5 Participants
Age, Categorical
Between 18 and 65 years
233 Participants
n=5 Participants
234 Participants
n=7 Participants
467 Participants
n=5 Participants
Age, Categorical
>=65 years
1 Participants
n=5 Participants
0 Participants
n=7 Participants
1 Participants
n=5 Participants
Age Continuous
36.8 years
STANDARD_DEVIATION 12.6 • n=5 Participants
35.7 years
STANDARD_DEVIATION 12.5 • n=7 Participants
36.3 years
STANDARD_DEVIATION 12.5 • n=5 Participants
Sex: Female, Male
Female
148 Participants
n=5 Participants
157 Participants
n=7 Participants
305 Participants
n=5 Participants
Sex: Female, Male
Male
86 Participants
n=5 Participants
77 Participants
n=7 Participants
163 Participants
n=5 Participants
Region of Enrollment
Canada
234 participants
n=5 Participants
234 participants
n=7 Participants
468 participants
n=5 Participants

PRIMARY outcome

Timeframe: day +7 post seasonal influenza vaccination (or placebo) to end of study

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)

Outcome measures

Outcome measures
Measure
Seasonal Influenza Vaccination
n=234 Participants
Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
Placebo
n=234 Participants
0.5 mL normal saline
Number of pH1N1 Influenza Infections as Diagnosed by PCR From Mid-turbinate Swab
2 participants
Interval 0.23 to 6.55
4 participants
Interval 1.17 to 9.59

Adverse Events

Seasonal Influenza Vaccination

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Placebo

Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Seasonal Influenza Vaccination
n=234 participants at risk
Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification
Placebo
n=234 participants at risk
0.5 mL normal saline
Congenital, familial and genetic disorders
death
0.00%
0/234 • Enrolment to March 28, 2010 - Maximum: 6 months
0.43%
1/234 • Number of events 1 • Enrolment to March 28, 2010 - Maximum: 6 months
Respiratory, thoracic and mediastinal disorders
pneumonia
0.43%
1/234 • Number of events 1 • Enrolment to March 28, 2010 - Maximum: 6 months
0.00%
0/234 • Enrolment to March 28, 2010 - Maximum: 6 months

Other adverse events

Adverse event data not reported

Additional Information

Dr. Brenda Coleman

Mount Sinai Hospital

Phone: 416-586-4800

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: LTE60