Safety and Protectiveness of the Seasonal Influenza Vaccine for 2010-2011 — PCIRNRT06  

Influenza Clinical Trial

Official title: A Randomized, Blinded, Placebo-controlled, Cross-over Study of the Safety and Immunogenicity of Trivalent, Inactivated Influenza Vaccine for 2010-2011

Status Completed

Clinical Trial Summary

The seasonal influenza vaccination program for 2010-2011 will be the first to follow the H1N1 pandemic of 2009. Many Canadians either had the H1N1 infection or the adjuvanted H1N1 vaccine. Both H1N1 infection and adjuvanted vaccine produced strong immune responses which could last for some time.

The seasonal influenza vaccine for this fall will be a "normal" product once again, without adjuvant. It will contain 3 strains of killed, split-apart viruses that might circulate this winter, including the H1N1 pandemic strain. It is theoretically possible that giving the H1N1-containing seasonal vaccine to people who still have some immunity to H1N1 virus could result in more frequent side-effects. However, there is no good evidence that pre-existing immunity to a strain in the vaccine does increase side-effects. In short, there could be nothing out of the ordinary this fall but it would be prudent to check this before public flu vaccination programs begin.

Clinical Trial Description

This study will assess the safety of seasonal influenza vaccination in people who had the adjuvanted H1N1 vaccine last year. It will also measure residual immunity to the H1N1 virus and immune responses to the seasonal vaccine. It will be carried out before the new vaccine is released for general use so that we have an accurate picture of vaccine safety and responses for other Canadians.

A total of 320 adults (64 at each site) 20 to 59 years old, are being asked to participate in this study. A research nurse will conduct a telephone screening with potential participants to determine if they are eligible for the study. Volunteers must have had adjuvanted H1N1 vaccine before January 31, 2010.

The study involves 2 vaccination visits 10 days part. At one visit seasonal vaccine will be given and at the other a placebo vaccine will be given. Which vaccine is given first will be determined by random chance, the details of which will not be released until study end. After each vaccination, there will be contacts 1 and 7 days later for a description of any symptoms experienced. A blood sample will be requested at the first and last visits (visit 3) to measure immune responses to the seasonal vaccine.

The study will take 21-38 days to complete, depending upon the vaccination sequence and availability. Total time required to take part is about 2.5 hours. The 3 study visits will occur at a clinic in Vancouver, Calgary, Ottawa, Montreal or Quebec City.

Each subject will be asked to keep daily notes of any changes at the injection site (pain, redness, swelling) and any general symptoms (such as headache, tiredness, body aches), including your oral temperature, for 7 days after each vaccination. Major health changes will be assessed for 21 days post 'vaccination'

A special Safety Board will review the results of the first vaccinations and advise whether it is reasonable to continue the study or not. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

• NCT number: NCT01140009
• Study type: Interventional
• Source: University of British Columbia
• Status: Completed
• Phase: Phase 2
• Start date: August 2010
• Completion date: September 2010