Phase 3
N=468
Does Seasonal Influenza Vaccination Affect the Incidence of pH1N1 Influenza?
Influenza
Bottom Line
View on ClinicalTrials.gov: NCT01001325 ↗Enrolled (actual)
468
Serious AEs
0.4%
Results posted
Jun 2011
Primary outcome: Primary: Number of pH1N1 Influenza Infections as Diagnosed by PCR From Mid-turbinate Swab — 2; 4 participants — p=0.685
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Fluviral influenza vaccine, 2009-2010 (Biological); Normal saline (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Mount Sinai Hospital, Canada
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of pH1N1 Influenza Infections as Diagnosed by PCR From Mid-turbinate Swab |
2; 4 | 0.685 |
Summary
Since the onset of the 2009 pandemic, several observational public health investigations in Canada have identified evidence that suggests that adults, particularly younger adults, who have previously received seasonal influenza vaccine are at increased risk of infection with the 2009 pandemic strain of H1N1 (pH1N1). Investigations in Australia, the United States and the United Kingdom have not identified this effect. While it is not possible to have an answer to whether this affect is real prior to the second wave of the 2009 pandemic, it remains vital to future influenza vaccination programs that the hypothesis that, in 2009, seasonal vaccine increases or decreases the risk of pH1N1 infection be confirmed or refuted.
The objective of this study is to determine whether Ontario adults aged 18-60 years who receive the 2009 seasonal influenza vaccine will be at a 2 fold or greater increased risk of infection with influenza pH1N1 during the second or third wave of the 2009 pandemic.
Eligibility Criteria
Inclusion Criteria
- 18 to 60 years old, inclusive, as of September 1st, 2009;
- understand the study, agree to its provisions, and give written informed consent prior to entry;
- available for follow-up during the study period;
- have convenient access to a computer with internet access and basic skills for use of the internet;
Exclusion Criteria
- planning to spend more than two consecutive weeks outside of Canada from October 1, 2009 to April 15th 2010.
- received immunoglobulin within six months of study entry;
- has already received a 2009 seasonal influenza vaccine (southern or northern hemisphere)
- has had laboratory-confirmed infection with 2009 H1N1 influenza
- is participating in a clinical trial that would result in the receipt of investigational medication during the study period;
- allergic to eggs, to influenza vaccine, or any components of the seasonal influenza vaccine
- has had a previous severe adverse event associated with an influenza vaccine
- has a significant chronic underlying illness that would warrant seasonal influenza vaccine in a usual year, or is known to be pregnant.
Data sourced from ClinicalTrials.gov (NCT01001325). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.