Does Seasonal Influenza Vaccination Affect the Incidence of pH1N1 Influenza?

NCT01001325 | Completed Phase 3 Results DMC

• 1 other identifier: CRT113936
• Study Type: interventional
• Target: 468
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Influenza

Keywords

influenza; vaccine; observer blind

Outcome Measures

Primary Outcomes (1)

• Number of pH1N1 Influenza Infections as Diagnosed by PCR From Mid-turbinate Swab

  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)

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

Study Arms (2)

Seasonal influenza vaccination

EXPERIMENTAL

Receipt of Fluviral seasonal (2009-2010, Canadian) influenza vaccination as per manufacturers specification

Biological: Fluviral influenza vaccine, 2009-2010

Placebo

PLACEBO COMPARATOR

0.5 mL normal saline

Biological: Normal saline

Interventions

Fluviral influenza vaccine, 2009-2010 BIOLOGICAL

0.5 mL intramuscular

Seasonal influenza vaccination

Normal saline BIOLOGICAL

0.5 mL intramuscular

Placebo

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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;

You may not qualify if:

• 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.

Sponsors & Collaborators

• Mount Sinai Hospital, Canada: lead
• GlaxoSmithKline: collaborator

Study Sites (2)

North York General Hospital

North York, Ontario, M2K 1E1, Canada

Location

Mount Sinai Hospital

Toronto, Ontario, M5G 1X5, Canada

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Saline Solution

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Limitations and Caveats

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).

Results Point of Contact

• Title: Dr. Brenda Coleman
• Organization: Mount Sinai Hospital

bcoleman@mtsinai.on.ca

416-586-4800

Study Officials

• Allison J McGeer, MD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

• Brenda L. Coleman, PhD

  MOUNT SINAI HOSPITAL

  PRINCIPAL INVESTIGATOR

• Natasha Crowcroft, MD

  Ontario Agency for Health Protection & Promotion

  PRINCIPAL INVESTIGATOR

• Karen Green, MSc

  MOUNT SINAI HOSPITAL

  STUDY DIRECTOR

• Kevin Katz, MD

  North York General Hospital

  STUDY DIRECTOR

• Mark Loeb, MD

  Hamilton Health Sciences Centre

  STUDY DIRECTOR

• Donald Low, MD

  MOUNT SINAI HOSPITAL

  STUDY DIRECTOR

• Shelly McNeil, MD

  Queen Elizabeth II Health Sciences Centre

  STUDY DIRECTOR

• Matthew Muller, MD, PhD

  Unity Health Toronto

  STUDY DIRECTOR

• Andrew Simor, MD

  Sunnybrook Health Sciences Centre

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2009
• First Posted: October 26, 2009
• Study Start: October 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: July 1, 2010
• Last Updated: April 20, 2012
• Results First Posted: June 15, 2011

Record last verified: 2012-04

Locations

CA (2)