Evaluation of Seasonal Influenza Vaccine for 2010-2011 in Young Children

NCT01180621 | Completed Phase 2 DMC

• 1 other identifier: PCIRN RT-07
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 4

Brief Summary

The seasonal influenza vaccination program for 2010-2011 will be the first to follow the H1N1 pandemic of 2009. Many children 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 trivalent inactivated product (regular seasonal influenza vaccine)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

Seasonal Influenza

Keywords

vaccine; Seasonal Influenza Vaccine; Influenza Vaccine; Vaccine Safety; Vaccine Immunogenicity; Fluviral 2010-2011

Outcome Measures

Primary Outcomes (1)

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

  Assessing reactogenicity on days 1-6 following TIV administration.

  7 days

Secondary Outcomes (1)

• To measure immune response to each component of TIV.

  42 days

Study Arms (1)

Fluviral

EXPERIMENTAL

0.25 mL Fluviral for children up to and including 35 months of age 0.50 mL Fluviral for children 36-59 months of age

Biological: Fluviral

Interventions

Fluviral BIOLOGICAL

0.25 mL Fluviral for children up to and including 35 months of age 0.50 mL Fluviral for children 36-59 months of age

Also known as: Influenza Virus Vaccine, Trivalent, Inactivated, Split Virion, Prepared in Eggs

Fluviral

Eligibility Criteria

• Age: 12 Months - 59 Months
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Written informed consent provided for the subject by a parent or legal guardian.
• Subjects whose parents the investigator believes can and will comply with the requirements of the protocol (i.e. return for follow-up visits, record safety observations, able to converse with study personnel including by telephone).
• Age 12-59 months at Visit 1, male or female
• Receipt of one or two doses of Arepanrix (adjuvanted H1N12009 vaccine, GlaxoSmithKline (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 Arepanrix after January 31st , 2010
• Receipt of non-study TIV (Trivalent Influenza Vaccine)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
• Receipt of blood or any blood-derived products within the past 3 months
• Chronic illness at a stage that could interfere with trial participation (stable health conditions are acceptable, such as diabetes, lung disease, heart conditions etc)
• Immune compromise as a result of a medical condition, transplantation or immunosuppressive medication, not including topical or aerosol medications
• Participation in any other research study involving a non-approved drug or medical device

Sponsors & Collaborators

• Dalhousie University: lead
• IWK Health Centre: collaborator
• Canadian Institutes of Health Research (CIHR): collaborator
• GlaxoSmithKline: collaborator

Study Sites (4)

ACHIEVE Research, Alberta Children's Hospital

Calgary, Alberta, Canada

Location

Vaccine Evaluation Center

Vancouver, British Columbia, Canada

Location

Candian Center for Vaccinology, Dalhousie University

Halifax, Nova Scotia, Canada

Location

McGill University Health Centre - Vaccine Study Centre

Montreal, Quebec, Canada

Location

Related Publications (1)

• Langley JM, Scheifele DW, Quach C, Vanderkooi OG, Ward B, McNeil S, Dobson S, Kellner JD, Kuhn S, Kollman T, MacKinnon-Cameron D, Smith B, Li Y, Halperin SA. Safety and immunogenicity of 2010-2011 H1N12009-containing trivalent inactivated influenza vaccine in children 12-59 months of age previously given AS03-adjuvanted H1N12009 pandemic vaccine: a PHAC/CIHR Influenza Research Network (PCIRN) study. Vaccine. 2012 May 14;30(23):3389-94. doi: 10.1016/j.vaccine.2012.03.046. Epub 2012 Mar 30.

  PMID: 22469860 DERIVED

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; Eggs

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Joanne Langley, MD

  Dalhousie University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 11, 2010
• First Posted: August 12, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2010
• Study Completion: April 1, 2011
• Last Updated: June 22, 2011

Record last verified: 2011-06

Locations

CA (4)