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

NCT01140009 | Completed Phase 2 DMC

• 1 other identifier: H10-01356
• Study Type: interventional
• Target: 324
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Influenza

Keywords

Vaccine; Seasonal Influenza vaccine; Influenza vaccine; Vaccine safety; Vaccine immunogenicity; Fluviral 2010/11

Outcome Measures

Primary Outcomes (3)

• To evaluate the safety of 2010-2011 seasonal trivalent vaccine (TIV)

  To evaluate the safety of 2010-2011 seasonal trivalent vaccine (TIV) in a convenience sample of adults being re-vaccinated with H1N12009 antigen, as soon as vaccine becomes available so as to inform subsequent use of the vaccine in public programs.

  12 weeks

• To measure immune responses to each component of TIV

  To measure immune responses to each component of TIV prior to and following seasonal vaccination to assess the immunogenicity of the new TIV vaccine.

  12 weeks

• To observe the persistence of anti-HAI responses to H1N12009

  To observe the persistence of anti-HAI responses to H1N12009 in a subset of subjects previously studied after vaccination with adjuvanted pandemic vaccine in late 2009 and to compare their peak responses to H1N12009 after the pandemic and TIV vaccinations.

  12 weeks

Secondary Outcomes (2)

• Vaccine-attributable rates of the observed adverse events

  12 weeks

• Immunogenicity analysis performed on the according-to-protocol (ATP) cohort

  12 weeks

Study Arms (2)

Group 1

PLACEBO COMPARATOR

FLuviral 2010/11Tri-valent Seasonal Influenza Vaccine (TIV)1st; saline placebo 10 days later

Biological: Fluviral 2010/11 Tri-valent Seasonal Influenza vaccine

Group 2

PLACEBO COMPARATOR

Saline placebo 1st; Fluviral 2010/11 Tri-valent Seasonal Influenza Vaccine (TIV)10 days later

Biological: Fluviral 2010/11 Tri-valent Seasonal Influenza vaccine

Interventions

Fluviral 2010/11 Tri-valent Seasonal Influenza vaccine BIOLOGICAL

Vaccination of .05mL of Fluviral vaccine will be injected once at either visit 1 or 2 depending upon randomization in the deltoid muscle of the non-dominant arm

Group 1

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written informed consent
• Can and will comply with the requirements of the protocol
• Age 20-59 years at Visit 1
• Receipt of one dose of Arepanrix (adjuvanted H1N12009 vaccine, GSK) in 2009 documented by written record or attested by a confident personal recollection (window for vaccination will be 1 October 2009 to January 31, 2010).

You may not qualify if:

• Systemic hypersensitivity to hens' eggs or to any other Fluviral S/F vaccine component such as thimerosal
• History of a life-threatening reaction to any influenza vaccine
• Receipt of non-study TIV for the 2010-2011 season
• Receipt of any live vaccine within 4 weeks or inactivated vaccine within one week of study entry or planned administration of any non-study vaccines during the study period
• Thrombocytopenia or any bleeding disorder that contraindicates IM injection or blood collection
• Pregnancy, at any stage of gestation
• Receipt of blood or any blood-derived products within 3 months prior to Visit 1
• Chronic illness at a stage that could interfere with trial participation (stable health conditions are acceptable, such as diabetes, lung disease, heart conditions etc)
• History of Guillain-Barre syndrome
• Immune compromise as a result of illness or immunosuppressive medication
• Participation in any other research study involving a non-approved drug or medical device
• Any other condition that may interfere with ability to comply with trial procedures, including abuse of alcohol, drug addiction or imposed confinement
• Current febrile illness or oral temperature of ≥ 38.0 °C

Sponsors & Collaborators

• University of British Columbia: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• GlaxoSmithKline: collaborator

Study Sites (5)

ACHIEVE Research, Alberta Children's Hospital

Calgary, Alberta, Canada

Location

Vaccine Evaluation Center

Vancouver, British Columbia, Canada

Location

The Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Location

McGill University Health Centre - Vaccine Study Centre

Montreal, Quebec, Canada

Location

Unité de Recherche en Santé Publique

Québec, Quebec, Canada

Location

Related Publications (1)

• Skowronski DM, Janjua NZ, De Serres G, Purych D, Gilca V, Scheifele DW, Dionne M, Sabaiduc S, Gardy JL, Li G, Bastien N, Petric M, Boivin G, Li Y. Cross-reactive and vaccine-induced antibody to an emerging swine-origin variant of influenza A virus subtype H3N2 (H3N2v). J Infect Dis. 2012 Dec 15;206(12):1852-61. doi: 10.1093/infdis/jis500. Epub 2012 Aug 7.

  PMID: 22872731 DERIVED

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

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

Study Officials

• David Scheifele, Dr.

  University of British Columbia

  PRINCIPAL INVESTIGATOR

• Simon Dobson, Dr.

  University of British Columbia

  STUDY DIRECTOR

• Laura Sauve, Dr.

  University of British Columbia

  STUDY DIRECTOR

• Tobias Kollmann, Dr.

  University of British Columbia

  STUDY DIRECTOR

• Keswadee Lapphra, Dr.

  University of British Columbia

  STUDY DIRECTOR

• Brian Ward, Dr.

  McGill University Health Centre - Vaccine Study Centre

  STUDY DIRECTOR

• Marc Dionne, Dr.

  Unité de Recherche en Santé Publique (CHUQ)

  STUDY DIRECTOR

• Vladimir Gilca, Dr.

  Unité de Recherche en Santé Publique (CHUQ)

  STUDY DIRECTOR

• Gaston DeSerres, Dr.

  Unité de Recherche en Santé Publique (CHUQ)

  STUDY DIRECTOR

• Curtis Cooper, Dr.

  The Ottawa Hospital Research Institute, University of Ottawa

  STUDY DIRECTOR

• Otto Vanderkooi, Dr.

  ACHIEVE Research, Alberta Children's Hospital, University of Calgary and Alberta Health Services

  STUDY DIRECTOR

• James Kellner, Dr.

  ACHIEVE Research, Alberta Children's Hospital, University of Calgary and Alberta Health Services

  STUDY DIRECTOR

• Judy MacDonald, Dr.

  ACHIEVE Research, Alberta Children's Hospital, University of Calgary and Alberta Health Services

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 7, 2010
• First Posted: June 9, 2010
• Study Start: August 1, 2010
• Primary Completion: September 1, 2010
• Study Completion: September 1, 2010
• Last Updated: April 15, 2015

Record last verified: 2015-04

Locations

CA (5)